Methods

• Study design: parallel RCT.

• Study duration: June 2008 to December 2009.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: Saudi Arabia.

• Setting: single centre.

• Adults > 18 years of either sex; single, unilateral, newly diagnosed condition; 4‐10 mm in transverse diameter; distal ureteral stones; normal kidney function.

• Number: treatment group 75; control group 75.

• Median age (range, years): treatment group 34 (20‐67); control group 36 (19‐72).

• Sex, M/F: treatment group: 50/25; control group: 53/22.

• Exclusion criteria: history of ipsilateral ureteral endoscopic or surgical manipulations or ESWL; patients with symptomatic UTI; those pregnant or lactating; patients already receiving alpha‐blockers, beta‐blockers, calcium channel antagonists, or corticosteroids; serious medical conditions; refused randomisation; lost to follow‐up during the study period.

Interventions

Treatment group

• Tamsulosin 0.4 mg once daily.

• Hydration, analgesia (diclofenac 100 mg) as needed.

Control group

• Placebo.

• Hydration, analgesia (diclofenac 100 mg) as needed.

Outcomes

• Stone passage rate.

• Stone passage time.

• Weekly stone passage rate.

• Episodes of renal colic.

• Need for analgesia.

• Drug adverse events.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Baseline assessment included non‐contrast spiral CT and furthermore weekly follow‐ups with KUB and US. NCCT was repeated at end of study to confirm stone status.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were allocated randomly in 1:1 ratio into either group."

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: "Using sealed envelopes."

Comment: This method of allocation concealment was considered to have low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "Both treating physicians and patients were blinded to randomization."

Comment: double‐blind and therefore low risk of bias.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No blinding of outcome assessments described.

Comment: No description was available; therefore this method of outcome assessment was considered to have unclear risk of bias.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: "17 patients were excluded due to not accepting randomization (6) and loss to follow‐up during study period (4 in group A and 7 in group B)."

Comment: Owing to relatively high numbers of exclusions and losses to follow‐up, incomplete outcome data were stated and risk of bias was unclear.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias therefore was considered to be low.

Other bias

Low risk

No quotes available. The study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: September 2004 to August 2007.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: India.

• Setting: single centre.

• Patients with stone < 10 mm in size in the distal ureter; evaluated with KUB, US, intravenous urography, and NCCT in selected patients.

• Number: treatment group 1: 34; treatment group 2: 34; control group: 34.

• Median age (range, years): treatment group 1: 31.4 (15‐56); treatment group 2: 38.7 (19‐60); control group: 35.3 (22‐58).

• Sex, M/F: treatment group 1: 26/8; treatment group 2: 28/6; control group: 24/10.

• Exclusion criteria: UTI; severe hydroureteronephrosis; diabetes mellitus; multiple stones; hypotension; pregnancy; previous spontaneous stone expulsion; distal ureteral surgery; history of intake of warfarin/alpha‐blocker/calcium channel blocker/steroids and cimetidine.

Interventions

Treatment group 1

• Tamsulosin 0.4 mg once daily.

Treatment group 2

• Alfuzosin 10 mg once daily.

Control group

• Placebo.

All groups received 75 mg diclofenac intramuscularly and were advised to drink at least 3 L of fluids.

Outcomes

• Stone passage.

• Time for passage.

• Total diclofenac dosage.

• Number of pain episodes.

Funding sources

None.

Declarations of interest

None.

Notes

Follow‐up weekly with KUB and US.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "The patients were randomized to 3 groups."

Comment: Randomisation was stated, but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, risk of allocation concealment was considered to be unclear.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: “Spontaneous stone expulsion was observed in 28 of 34 patients (82.3%) in group 1, 24 of 34 (70.5%) in group 2, and 12 of 34 (35.2%) patients in group 3.”

Comment: Stone expulsion rate was reported for all participants; therefore, probably none were lost to follow‐up and accordingly risk of bias was considered low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. The study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: 1 January to 31 October 2010.

• Follow‐up/Treatment duration: 28 days.

Participants

• Country: Pakistan.

• Setting: single centre.

• Patients with stone ≤ 8 mm in the distal 1/3 ureter; evaluated with KUB, US, or IVU (if required).

• Number: treatment group: 49; placebo group: 48.

• Mean age, SD, years: overall: 36.34; range: 18‐57.

• Sex, M/F: not reported.

• Exclusion criteria: age < 18 years; ureteric obstruction; distal ureteric stricture; previous ureteral surgery; solitary kidney; aberrant ureteral anatomy (e.g. ureteral ectopia, ureterocoele, mega‐ureter); UTI; radiolucent stone.

Interventions

Treatment group

• Tamsulosin 0.4 mg once daily.

Placebo group

• Placebo.

Both groups were given tab diclofenac sodium 50 mg, 1 tab 8 hourly for pain control on required basis.

Outcomes

• Stone passage rate.

• Time for stone passage.

• Need for analgesics.

• Need for hospitalisation.

• Drug adverse effects.

Funding sources

None.

Declarations of interest

None.

Notes

Participants were evaluated with plain X‐ray KUB after 2 weeks and 4 weeks.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "Patients were randomly assigned into one of the two groups."

Comment: Randomisation was stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, risk of allocation concealment was considered to be unclear.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: “Three patients lost to follow up, therefore 97 out of 100 patients were evaluated.”

Comment: Small number of participants were lost to follow‐up; accordingly, risk of bias was considered low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered low.

Methods

• Study design: RCT.

• Study duration: March 2008 and November 2009.

• Follow‐up/Treatment duration: 30 days.

Participants

• Country: Saudi Arabia.

• Setting: single centre.

• Patients with stone ≤ 10 mm in the distal ureter; evaluated with KUB, US, and NCCT in selected patients.

• Number: treatment group 1: 29; treatment group 2: 30; control group: 28.

• Mean age, SD, years: treatment group 1: 40.7 ± 14.8; treatment group 2: 41.1 ± 15.2; control group: 38.9 ± 13.3.

• Sex, M/F: treatment group 1: 19/10; treatment group 2: 18/12; control group: 19/9.

• Exclusion criteria: age < 18 years; pregnant or lactating women; history of previous surgery on the ipsilateral ureter; stone larger than 10 mm; multiple stones; bilateral ureteric stones; solitary kidney; UTI; moderate or severe hydronephrosis; currently on alpha‐blocker therapy; known allergy to tamsulosin or alfuzosin; contraindications to non‐steroidal anti‐inflammatory agents; renal insufficiency.

Interventions

Treatment group 1

• Tamsulosin 0.4 mg once daily.

Treatment group 2

• Alfuzosin 10 mg once daily.

Control group

• Diclofenac sodium only.

All groups received 50 mg diclofenac every 12 hours for 1 week, then 75 mg diclofenac intramuscularly as needed up to 2 times per day.

Outcomes

• Stone passage rate.

• Time for stone passage.

• Frequency of pain attacks.

• Complications of medications.

Funding sources

None.

Declarations of interest

None.

Notes

Follow‐up visits on a weekly basis with urine analysis, serum creatinine measurement, plain X‐ray KUB, and abdominal ultrasonography. Abdominal CT was performed for participants with radiolucent stones if the stone was not expulsed by the end of study.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "A total of 90 patients with distal ureteral stones ≤10 mm in diameter were randomly divided into 3 equal groups and given medications for 30 days."

Comment: Randomisation was stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No quotes available. No intention‐to‐treat analysis.

Comment: Owing to lack of intention‐to‐treat analysis, risk of attrition bias was considered to be unclear.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: double‐blinded RCT.

• Study duration: May 2007 to May 2009.

• Follow‐up: 4 weeks.

Participants

• Country: Qatar.

• Setting: single centre.

• Patients with distal ureteral stones of 10 mm or smaller, evaluated by KUB, US, and NCCT before treatment.

• Number: treatment group: 50; control group: 50.

• Mean age ± SD, years: treatment group: 37.18 ± 9.38; control group: 36.13 ± 9.32.

• Sex, M/F: treatment group: 32/18; control group: 29/21.

• Exclusion criteria: age < 18 years; non‐radiopaque stones; multiple stones; severe hydronephrosis; pregnancy; hypotension; peptic ulcer; history of endoscopic or open ureteral surgery; use of calcium channel blocker.

Interventions

Treatment group

• Tamsulosin 0.4 mg once daily.

Control

• Placebo.

Outcomes

• Stone expulsion rate.

• Time for stone passage.

• Number of pain episodes.

• Need for diclofenac injection.

• Total diclofenac dosage.

• Blood pressure.

• Possible side effects.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Sample size calculated.

Weekly follow‐up with KUB, US, and urine analysis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were randomized between study and placebo medications using a computer‐generated random number assignment, adjusted at a ratio of 1:1." Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: "Randomization data were kept strictly confidential, in sealed envelops, accessible only to the pharmacist at the end of the study."

Comment: This method of allocation concealment was considered to have low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "The investigators and patients were masked to the type of the treatment throughout the study."

Comment: double‐blind; therefore low risk of bias.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: “The investigators and patients were masked to the type of the treatment throughout the study.”

Comment: Personnel responsible for outcome assessments were blinded; therefore risk of detection bias was considered to be low.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote: “Four patients in the placebo group were lost to follow‐up.”

Comment: Four participants in the placebo group were lost to follow‐up and were excluded from analysis. It is unclear whether this had a clinically relevant impact on the intervention effect estimate; therefore risk of attrition bias was considered to be unclear.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias therefore was considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered low.

Methods

• Study design: RCT.

• Study duration: December 2013 to June 2015.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: India.

• Setting: single centre.

• Patients with stone ≤ 10 mm in the distal ureter; evaluated with KUB, US, and NCCT in selected patients.

• Number: treatment group 1: 40; treatment group 2: 40; control group: 40.

• Mean age, SD, years: treatment group 1: 35 ± 8.5; treatment group 2: 32 ± 7.5; control group: 34 ± 8.5.

• Sex, M/F: treatment group 1: 28/12; treatment group 2: 32/8; control group: 30/10.

• Exclusion criteria: age < 18 years; previous surgery on ipsilateral ureter; bilateral ureteral calculus; multiple stones; solitary kidney; intolerant or hypersensitive to alpha‐blockers; contraindicated for NSAIDs; renal insufficiency; pregnant and lactating women

Interventions

Treatment group 1

• Tamsulosin 0.4 mg once daily.

Treatment group 2

• Silodosin 8 mg once daily.

Control group

• All groups received 50‐100 mg diclofenac.

Outcomes

• Stone passage rate.

• Blood pressure.

• Time for stone passage.

• Number of pain attacks.

• Hospital re‐admissions.

• Adverse effects.

Funding sources

None.

Declarations of interest

None.

Notes

Follow‐up visits on a weekly basis with urine analysis, serum creatinine measurement, plain X‐ray KUB, and abdominal ultrasonography. Abdominal CT was performed for all participants by end of study.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No quote available.

Comment: Randomisation was stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Out of the 120 patients included in the study, patients were divided randomly into three groups of 40 patients."

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

High risk

No quotes available.

Comment: Blood pressure was not reported in the Results section (as a secondary outcome measurement); therefore risk of reporting bias was considered to be high.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered low.

Methods

• Study design: RCT.

• Study duration: March to July 2009.

• Follow‐up: 10 days.

Participants

• Country: Turkey.

• Setting: single centre.

• Patients with distal ureteral stones < 10 mm; > 17 years; diagnosed with KUB, US, and CT if necessary.

• Number: treatment group 1: 31; treatment group 2: 30; control group: 29.

• Mean age ± SD, years: treatment group 1: 42.4 ± 16.1; treatment group 2: 46.5 ± 16.5; control group: 43.5 ± 16.6.

• Sex, M/F: treatment group 1: 22/9; treatment group 2: 17/13; control group: 19/10.

• Exclusion criteria: presence of UTI; solitary kidney; severe hydroureteronephrosis; renal insufficiency; diabetes mellitus; multiple stones; bilateral stones; hypotension; pregnancy; previous spontaneous stone expulsion; previous distal ureteral surgery; history of intake of nifedipine, alpha‐adrenergic blockers, calcium antagonists, and steroids

Interventions

Treatment group 1

• Tamsulosin 0.4 mg once daily.

Treatment group 2

• Rowatinex 100 mg once daily.

Control group

• Diclofenac 100 mg once daily.

Participants in groups 1 and 2 received diclofenac when needed (100 mg once daily).

Outcomes

• Mean stone expulsion time.

• Stone expulsion rate.

• Mean stone size.

• Stone location.

• Stone site.

• Additional analgesic requirement.

• Number of ureteral colics.

• Upper urinary tract dilation.

• Adverse events.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Missing data on stone expulsion rate.

Follow‐up was 10 days, then again KUB, US, or CT.

All participants were suggested to drink at least 2 L of drinking water daily.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: “Patients were randomized in 3 groups.”

Comment: Randomisation was stated, but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

High risk

No quotes available.

Comment: No predefined endpoints were mentioned; therefore risk of reporting bias was considered to be high.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered low.

Methods

• Study design: RCT.

• Study duration: June 2007 until July 2008.

• Follow‐up: 4 weeks.

Participants

• Country: Iran.

• Setting: single centre.

• Patients with distal ureteral stones and UVJ stones 3 to 6 mm; 18‐60 years; diagnosed with KUB and US.

• Number: treatment group: 50; control group: 46.

• Age limits, years: treatment group: 20‐50; control group: 19‐54.

• Sex, M/F: treatment group: 21/29; control group: 14/32.

• Exclusion criteria: radiolucent stone on KUB; acute hydronephrosis (grades 2 and 3) on sonography; presence of UTI; history of peptic ulcer disease; systolic blood pressure < 100; consumers of calcium antagonist drugs; solitary kidney; diabetes mellitus; pregnancy; previous distal ureteral surgery; creatinine over 1.4 for males and 1.2 for females; pain resistant to conservative treatment; NSAID intolerance or adverse events of tamsulosin during the study; participant withdrawal from the study at any time; occurrence of any unforeseen complications during the study.

Interventions

Control group

• Standard pain medication (indomethacin).

Treatment group

• Tamsulosin 0.4 mg once daily.

Researchers emphasised that all participants should drink 2 L of water daily.

Outcomes

• Stone expulsion time.

• Stone expulsion rate.

• Mean stone size.

• Stone location.

• Amount of analgesic consumption.

• Possible complications caused by stones during the study period.

• Possible side effects from medications or intolerance recorded and used for statistical analysis.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Follow‐up was every 2 weeks with KUB, US, or CT.

Not all abbreviations were explained in the text.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: “patients were randomly assigned to a control group (n = 46) and study group (n = 50).”

Comment: Randomisation was stated but no information on method used was available; therefore selection bias was considered to have unclear risk.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No quotes available. No intention‐to‐treat analysis.

Comment: Owing to lack of intention‐to‐treat analysis, risk of attrition bias was considered to be unclear.

Selective reporting (reporting bias)

High risk

No quotes available.

Comment: Results on pain episodes were not reported; therefore risk of reporting bias was considered to be high.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore we considered risk of other bias to be low.

Methods

• Study design: prospective RCT.

• Study duration: December 2007 and November 2008.

• Follow‐up: 3 weeks.

Participants

• Country: Spain.

• Setting: single centre.

• Patients with distal ureteral stones diagnosed with KUB, ultrasound, and/or urography.

• Number: treatment group: 35; control group: 35.

• Mean age of both study groups not mentioned.

• Sex, M/F: not mentioned.

• Exclusion criteria: urinary infection; anatomical alterations; multiple lithiases; urinary derivation; other factors hindering the removal of calculi.

Interventions

Control group

• Standard pain medication (ibuprofen, tramadol).

Treatment group

• Tamsulosin 0.4 mg once daily and same pain medication as control group.

Researchers emphasised that all participants should drink 2 L of water daily.

Outcomes

• Stone expulsion time.

• Stone expulsion rate.

• Amount of analgesic consumption.

• Possible complications caused by stones during the study period.

• Possible side effects from medications or intolerance recorded and used for statistical analysis.

• Need for hospitalisation.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Assessment of trial results was conducted at 10 days and 30 days.

On day 30, stone expulsion was assessed by plain X‐ray, ultrasonography, or urography.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: “Patients were divided randomly into 2 treatment groups.”

Comment: Randomisation was stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: single‐centre RCT.

• Study duration: unclear.

• Follow‐up/treatment: maximum 2‐week treatment.

Participants

• Country: Italy.

• Setting: single centre.

• Patients with symptomatic ≤ 10 mm distal ureteral stones, diagnosed with NCCT.

• Number: treatment group: 50; control group: 46.

• Mean age ± SD, years: treatment group: 46.3 ± 10.9; control group: 44.5 ± 11.3.

• Sex, M/F: treatment group: 36/14; control group: 26/20.

• Exclusion criteria: UTI; severe hydronephrosis; diabetes; ulcer disease; hypotension or hypertension treated with alpha‐blockers or calcium antagonists; pregnancy; multiple stones; history of spontaneous stone expulsion; ureteral stricture.

Interventions

Treatment group

• Tamsulosin 0.4 mg once daily.

• Standard therapy

  • Diclofenac 100 mg daily.

Control group

• Standard therapy

  • Diclofenac 100 mg daily.

• Aescin (an anti‐oedema extract of the horse chestnut tree) 80 mg daily.

Outcomes

• Stone expulsion rate.

• Expulsion time.

• Need for analgesics.

• Need for hospitalisation.

• Drug side effects.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Aescin = standard therapy at this centre.

Included participants from the study by Autorino et al 2005.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “Randomization, not blinded, was performed using a stratified permuted randomization algorithm.”

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants were included in the analysis; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: prospective RCT.

• Study duration: NS.

• Follow‐up/Treatment duration: up to 4 weeks, or until an alternative treatment was given.

Participants

• Country: Uzbekistan.

• Setting: single centre.

• Patients with distal ureteral stones.

• Number: treatment group: 31; control group: 32.

• Mean age ± SD, years: NS.

• Sex, M/F: NS.

• Exclusion criteria: NS.

Interventions

Treatment group

• Doxazosin 4 mg once daily.

• Diclofenac 75 mg on demand.

Control group

• Diclofenac 75 mg on demand.

Outcomes

• Stone expulsion rate.

• Stone expulsion time.

• Need for analgesics.

• Need for hospitalisation.

• Drug side effects.

• Numbers and intensity of renal/ureteral colic.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Conference abstract.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: “were randomly divided into.”

Comment: Randomisation was stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of attrition bias was considered to be unclear.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Unclear risk

No quotes available. Baseline data are missing.

Comment: Owing to lack of information at baseline, risk of other bias was considered to be unclear.

Methods

• Study design: RCT.

• Study duration: 11 March 2011 to 11 September 2011.

• Follow‐up/Treatment duration: 28 days.

Participants

• Country: Pakistan.

• Setting: single centre.

• Patients with lower ureteric stones.

• Number: treatment group: 30; control group: 30.

• Mean age ± SD, years: overall: 33.15 ± 8.97; control group: 33.87 ± 9.61; tamsulosin group: 32.43 ± 8.33.

• Sex, M/F: control group: 19/11; tamsulosin group: 18/12.

• Exclusion criteria: obstruction; stone size > 1 cm; UTI.

Interventions

Treatment group

• Tamsulosin 4 mg once daily.

Control group

• Diclofenac 50 mg on demand twice daily.

Outcomes

• Stone size.

• Stone passage rate.

• Stone expulsion time.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “The patients satisfying the inclusion criteria were randomly divided in to 2 groups by random number table.”

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

High risk

No quotes available.

Comment: Primary outcomes were not prespecified; therefore risk of reporting bias was considered to be high.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: January 2010 and February 2011.

• Follow‐up/Treatment duration: 28 days.

Participants

• Country: Turkey.

• Setting: single centre.

• Stones in the lower one‐third of the ureter.

• Number: treatment group 1: 25; treatment group 2: 25; control group: 25.

• Mean age ± SD, years: 36.8 ± 11.3 overall.

• Sex, M/F: not mentioned.

• Exclusion criteria: proximal or intramural part of ureteral stone; active urinary tract infection; ureterohydronephrosis; acute renal failure; fever; multiple ureteral stones; history of surgery or endoscopic procedure of urolithiasis; chronic renal failure; diabetes mellitus; peptic ulcer; concomitant treatment with alpha‐blocker and beta‐blocker, calcium antagonists, or nitrates; pregnancy; lactation; patient desire for immediate stone removal.

Interventions

Treatment group 1

• Tamsulosin 0.4 mg once daily.

Treatment group 2

• Nifedipine 30 mg once daily.

Control group

• Diclofenac sodium 50 mg.

All participants were encouraged to maintain water intake of 2‐2.5 L/d.

Outcomes

• Stone expulsion rate.

• HU of stones.

• Expulsion time.

• Rate of pain relief therapy.

• Mean analgesic consumption.

• Drug side effects.

Funding sources

None.

Declarations of interest

None.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “Randomization was performed using the Power Analysis & Sample Size Software (PASS_ ) for Windows (NCSS Inc., Kaysville, UT). According to the software, the patients were randomly assigned to one of the following three groups.”

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of reporting bias was considered to be unclear.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: prospective RCT.

• Study duration: December 2015 and May 2017.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: Turkey.

• Setting: single centre.

• Married male patients over the age of 18 years with opaque distal ureteral stones measuring 5–10 mm.

• Number: treatment group 1: 60; sexual intercourse group 2: 66; control group: 64.

• Mean age ± SD, years: group 1: 34.4 ± 13.5; group 2: 38.66 ± 14.1; group 3: 36.92 ± 12.4.

• Sex, M/F: only male patients.

• Exclusion criteria: proximal or intermediate ureter stones (stones on the ureter‐iliac artery cross); stones < 5 mm; stones ≥ 10 mm; multiple ureter stones; < 18 years of age; urinary infection; fever; renal insufficiency; high creatinine level; pregnancy; severe hydroureteronephrosis; endoscopic or open ureteral surgery history; ureteral stenosis; vesicoureteral reflux; neurogenic bladder; unmarried patients; erectile dysfunction; more than 1 sexual intercourse and masturbation statement per week for group 1 and group 3; fewer than 3 sexual intercourse statements per week for group 2.

Interventions

Treatment group 1

• Tamsulosin 0.4 mg once daily.

Treatment group 2

• Sexual intercourse.

Control group

• As standard medical therapy, all participants were recommended daily intake of liquids to urinate at least 1.5–2 L, and 75 mg of diclofenac injected when needed for pain.

Outcomes

• Number of pain.

• Need for pain killer injection.

• Number of masturbation and sexual intercourse attempts during follow‐up.

• Stone expulsion rate.

Funding sources

None.

Declarations of interest

None.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: "randomly divided into three groups according to the order of arrival (1:1:1 ratio)."

Comment: This method of random sequence generation was considered to have high risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: "all tomography and direct urinary system graphy of the patients were analyzed and confirmed by a urologist blinded to the group of the patients."

Comment: Risk of detection bias was considered to be low.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "A total of 13 patients, 6 in group 1, 4 in group 2, and 3 in group 3, were excluded from the study because they were lost in follow‐up. 5 patients in group 1 and 3 patients in group 3 were also excluded from the study because they declared more than one sexual intercourse or masturbation per week."

Comment: 21/211 participants were lost to follow‐up and were equally divided over the 3 groups; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

High risk

No quotes available. Only males were included in the study.

Comment: Potential selection bias; therefore high risk of other bias.

Methods

• Study design: prospective double‐blind RCT.

• Study duration: April 2007 and February 2009.

• Follow‐up/Treatment duration: 7 days.

Participants

• Country: USA.

• Setting: single centre.

• All ureteral stones.

• Number: treatment group: 53; placebo group: 47.

• Mean age: treatment group: 40.62; placebo group: 44.52.

• Sex, M/F: treatment group: 26% male; placebo group: 30% male.

• Exclusion criteria: younger than 18 years; stone larger than 1 cm; infected stones; obstructing stones in solitary kidneys; currently taking Levitra, nifedipine, or steroids; requiring immediate surgical intervention; pregnant; already taking tamsulosin before enrolment.

Interventions

Treatment group

• Tamsulosin 0.4 mg once daily and standard analgesia (Vicodin and ibuprofen).

Placebo group

• Placebo drug and standard analgesia (Vicodin and ibuprofen).

Outcomes

• Stone expulsion rate.

• Pain score.

• Drug side effects.

• Mean analgesic consumption.

Funding sources

None.

Declarations of interest

None.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: "using a convenience sample."

Comment: This method of random sequence generation was considered to have high risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "double‐blinded, placebo‐controlled."

Comment: double‐blind; therefore low risk of bias.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Quote: "Of the 127 patients enrolled during this study, 15 were lost to follow‐up, and 12 received surgical intervention before the 7‐day mark, leaving 100 patients for analysis."

Comment: Owing to a reasonable number of participants lost to follow‐up, risk of attrition bias was considered to be high.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: DB RCT.

• Study duration: June 1999 to January 2002.

• Follow‐up/Treatment duration: probably 7 days.

Participants

• Country: Slovakia.

• Setting: inpatients.

• Patients, 17‐76 years, with X‐ray‐verified lower urinary tract stones < 10 mm.

• Number: treatment group: 51; control group: 53 enrolled/51 evaluated.

• Age range, years: treatment group: 18‐76; control group: 17‐74.

• Sex, M/F: treatment group: 32/19; control group: 33/18.

• Exclusion criteria: pregnant women; new and decompensated diabetes mellitus; febrile state; advanced ureterohydronephroses; UTI; grave polyvalent allergies.

Interventions

Treatment group

• Tamsulosin 0.4 mg.

• Standard therapy.

Control group

• Standard therapy

  • 1 amp Tramal 50 mg – analgeticum + 1 amp diazepam 5 mg – anxiolyticum in 150 mL physiological saline infusion solution applied IV.

• These participants were also given the following per os: 3 × 2 tablets Yellon per 20 mg – antiexudativum and non‐steroid antirheumatic Veral, 3 times daily per 50 mg.

All participants were made to keep a drinking regimen of at least 2.5 L of water or weak tea daily.

Outcomes

• Stone expulsion rate.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Study authors stated the study model was a double blind RCT but described no blinding.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "we have applied a double blind randomized study."

Comment: Randomisation was stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "As two pts. were excluded from group “A” because during treatment they developed acute obstruction pyelonephritis, both groups consisted of a rather unusual identical number of experimental and standardly treated pts. (51)."

Comment: In the light of the small number of participants lost to follow‐up, risk of attrition bias was stated as low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: September 2008 and June 2011.

• Follow‐up/Treatment duration: 28 days.

Participants

• Country: Korea.

• Setting: single centre.

• One single lower ureteral stone, measuring 4‐10 mm.

• Number: treatment group 1: 41; treatment group 2: 30; treatment group 3: 36; control group: 34.

• Mean age ± SD, years: treatment group 1: 45.07 ± 13.77; treatment group 2: 45.50 ± 11.09; treatment group 3: 42.33 ± 12.58; control group: 43.65 ± 10.87.

• Sex, M/F: treatment group 1: 31/10; treatment group 2: 20/10; treatment group 3: 25/11; control group: 18/16.

• Exclusion criteria: UTI; moderate or severe hydronephrosis; hypotension; single kidney; bilateral ureteral stones; history of previous surgery on the ipsilateral ureter; currently taking an alpha‐blocker, steroid, or calcium channel blocker; renal insufficiency; < 18 years of age; pregnant or lactating women.

Interventions

All participants received trospium chloride (50 mg 3 times daily). All participants received initial treatment of 90 mg diclofenac by intramuscular injection and 5 mg cimetropium bromide by intravenous injection, with a second dose after 30 minutes or 1 hour if necessary.

Treatment group 1

• Tamsulosin 0.2 mg once daily.

Treatment group 2

• Tamsulosin 0.2 mg twice daily.

Treatment group 3

• Alfuzosin 10 mg once daily.

Control group

• Solely trospium chloride.

Outcomes

• Stone size.

• Stone expulsion rate.

• Stone expulsion time.

• Drug side effects.

Funding sources

None.

Declarations of interest

None.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “The randomization list was generated by using the permuted block method.”

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: “... was concealed from the patient‐enrolling investigators (confined with a doctor assisting in the procedure but not participating in the study).”

Comment: This method of allocation concealment was considered to have low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: double‐blind placebo‐controlled RCT.

• Study duration: unknown.

• Follow‐up/Treatment duration: 90 days.

Participants

• Country: South Korea.

• Setting: multi‐centre.

• Patients > 20 years of age with a single ureteral stone. The maximal diameter of the stones was 3 ± 10 mm.

• Number: treatment group: 64; placebo group: 60.

• Mean age ± SD, years: treatment group: 48.1 ± 14.2; placebo group: 42.33 ± 12.58.

• Sex, M/F: treatment group: 49/15; placebo group: 41/19.

• Exclusion criteria: presence of multiple ureter stones; renal or hepatic dysfunction; febrile urinary tract infection; breastfeeding or pregnant women; solitary kidney; hypersensitivity to naftopidil; current use of alpha‐blockers, calcium channel blockers, or corticosteroid within 4 weeks; moderate to severe cardiovascular or cerebrovascular disease; significant active medical illness or genetic disorders.

Interventions

Treatment group

• Naftopidil 75 mg once daily.

Placebo group

• All participants received aceclofenac 100 mg or combination treatment with tramadol 37.5 mg and acetaminophen 325 mg.

Outcomes

Primary outcome measures

• Stone‐free rate.

Secondary outcome measures

• Stone‐free rate at 28th day of study.

• Quantity of analgesics used.

• Rate of active treatment.

Funding sources

None.

Declarations of interest

None.

Notes

Participants were followed up at days 14 (visit 1), 28 (visit 2), 60 (visit 3), and 90 (visit 4) after initiation of medication.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomization was carried out by the Medical Research Collaboration Center of Seoul National University Bundang Hospital using random permuted blocks of different sizes. The size of the next block was randomly chosen from the available block sizes."

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: "The size of the next block was randomly chosen from the available block sizes. Randomization was stratified by each recruiting study site."

Comment: This method of allocation concealment was considered to have low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "One person packed the 14‐day supply of tablets for each patient. All study staff at all hospitals were blinded to treatment allocation and remained blind until the end of the trial."

Comment: double‐blind; therefore low risk of bias.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available. Figure 1 shows a detailed flow diagram of participant follow‐up, including information regarding loss to follow‐up, exclusion due to adverse events, or need for intervention.

Comment: Detailed information on participant follow‐up was available; risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Information on primary and secondary outcomes was presented in detail in the protocol at www.clinicaltrials.gov. Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: September 2013 to October 2014.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: Turkey.

• Setting: single centre.

• Patients with stone measuring ≤ 6 mm in the distal ureter; evaluated with KUB, US, and NCCT in selected patients.

• Number: treatment group: 27; control group: 30.

• Mean age, SD, years: treatment group: 39.3 ± 8.1; control group: 34 ± 10.4.

• Sex, M/F: treatment group: 27/0; control group: 30/0.

• Exclusion criteria: Aged < 18 years; did not have an active sexual partner; described erectile dysfunction; diabetes mellitus; a stone measuring > 6 mm; a stone located in the mid‐ureter or proximal ureter (above iliac vessels); non‐opaque or multiple stones; urinary tract infection; severe hydronephrosis; history of stone passage or previous endoscopic or open ureteral surgery; high serum creatinine levels; previous use of a‐1‐adrenergic receptor or calcium channel blockers.

Interventions

Treatment group

• Tamsulosin 0.4 mg once daily.

Control group

• All groups received 75 mg diclofenac injections when needed. Buscopan 10 mg twice daily orally.

Outcomes

• Stone passage rate.

• Time to stone passage.

• Number of pain episodes.

• Need for diclofenac injections.

• Number of sexual intercourse attempts.

Funding sources

None.

Declarations of interest

None.

Notes

Follow‐up visits on a weekly basis with urine analysis, plain X‐ray KUB, and abdominal ultrasonography.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “The patients were randomly divided into 3 groups with the random number table envelope method.”

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: “The names of the groups were written on small papers with the same size, they were folded, put in an envelope, and drawn by the patients.“

Comment: This method of allocation concealment was considered to have low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quote available. Participants were blinded, and blinding of doctors was not described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: “On follow‐up, plain urinary tract x‐ray images of the patients were seen and analyzed by an urologist (MFK) blinded to the group of the patients.“

Comment: Risk of detection bias was considered to be low.

Incomplete outcome data (attrition bias)
All outcomes

High risk

No quote available. 13/57 participants lost to follow‐up equally distributed among control and treatment groups.

Comment: Owing to a reasonable number of participants lost to follow‐up (> 20%), risk of attrition bias was considered to be high.

Selective reporting (reporting bias)

High risk

No quote available. No number of pain episodes described in the Results section (although this was a secondary outcome measurement). Furthermore adverse effects were predefined in Methods section and were not described in Results section.

Comment: Owing to inconsistent reporting, risk of reporting bias was considered to be high.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: NS.

• Follow‐up/Treatment duration: 1 week.

Participants

• Country: Korea.

• Setting: multi‐centre.

• Patients with ureteral stones.

• Number: treatment group: 19; control group: 21.

• Mean age ± SD, years: treatment group: 54.05 ± 12.63; control group: 45.19 ± 12.27.

• Sex, M/F: treatment group: 12/7; control group: 12/9.

• Exclusion criteria: uncontrolled pain with conservative therapy; multiple stones; pregnancy; SCr ≥ 2.5 mg/dL; prior ureteral surgery; urinary tract obstruction; ureteral splints.

Interventions

Treatment group (group 3)

• Tamsulosin 0.2 mg.

Control group (group 4)

• Diclofenac sodium for 1 week.

Four treatment arms, of which the first 2 underwent ESWL (groups 1 and 2); groups 3 and 4 did not want to undergo ESWL.

Outcomes

• Stone clearance.

• Change in pain score.

Funding sources

Study was supported by research funds from Astellas Phama Korea, Inc.

Declarations of interest

None stated.

Notes

Dong Il Kang; only the abstract was written in English and therefore was interpretable.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

No quotes available.

Comment: Participants were those who did not want to undergo ESWL; therefore risk of selection bias was considered to be high.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, risk of allocation concealment was considered to be unclear.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of attrition bias was considered to be unclear.

Selective reporting (reporting bias)

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of reporting bias was considered to be unclear.

Other bias

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of other sources of bias was considered to be unclear.

Methods

• Study design: prospective RCT.

• Study duration: NS.

• Follow‐up/treatment duration: 4 weeks.

Participants

• Country: Egypt.

• Setting: single centre, outpatient clinic.

• Patients with distal ureteral calculi.

• Number: treatment group: 28; control group: 26.

• Mean age ± SD, years: treatment group: 32.8 ± 9.5; control group: 32.1 ± 9.2.

• Sex, M/F: treatment group: 18/10; control group: 16/10.

• Exclusion criteria: UTI; ureteral strictures; renal impairment; solitary functioning kidney; diabetes mellitus; hepatic insufficiency; severe hydronephrosis; hypotension; pregnancy; lactation; sensitivity to alpha‐blockers; use of alpha‐1‐blockers, beta‐blockers, sildenafil, ketoconazole, itraconazole, ritonavir.

Interventions

Treatment group (group 2)

• Alfuzosin 5 mg twice daily.

• Diclofenac 75 mg IM on demand.

Control group (group 1)

• Diclofenac 75 mg IM on demand.

All participants were asked to drink > 2 L of water daily and received diclofenac 75 mg IM on demand.

Outcomes

• Stone passage rate.

• Number of pain episodes.

• Pain level.

• Analgesic consumption.

• Number of hospital revisits.

• Drug adverse events.

• Complications.

Funding sources

Welcome Trust: Howard Hughes Medical Institute and others.

Declarations of interest

None.

Notes

Article 2015.

Conference abstract 2014.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “randomly assigned to either the control group or the alfuzosin group based on a computer‐generated random table.”

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: “This was a prospective, randomized, open–label, controlled study.”

Comment: open label trial; therefore risk of performance bias was considered to be high.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Quote: “This was a prospective, randomized, open–label, controlled study.“

Comment: open label trial; therefore risk of detection bias was considered to be high.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quote available.

Comment: All participants were included in the analysis; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: prospective DB RCT.

• Study duration: October 2006 to October 2010.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: Egypt.

• Setting: single centre.

• Patients with distal third ureteral stones.

• Number: treatment group: 48; placebo group: 46.

• Mean age ± SD, years: group 1: 36.2 ± 6; group 2: 35.3 ± 5.7.

• Sex, M/F: NS.

• Exclusion criteria: UTI; ureteral strictures; renal impairment; solitary functioning kidney; pregnancy; lactation; sensitivity to alpha‐blockers.

Interventions

Group 1: placebo group.

Group 2: tamsulosin group.

Group 3: Uralyt group.

Group 4: Uralyt and tamsulosin group.

All participants were advised to increase fluid intake to more than 2 L per day and to receive IM injection of 75 mg of diclofenac sodium.

Outcomes

• Mean stone size.

• Analgesic needs.

• Stone passage rate.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Non‐enhanced spiral CT was done at the end of study period for all participants.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “Patients were prospectively randomized through a computer generated randomization process into four equal groups.”

Comment: This method of random sequence generation was considered to have low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: “The investigators and the patients were blinded to the treatment given, until the end of the study.”

Comment: Randomisation method was described and would not allow investigator/participant to know or influence the intervention group before eligible participant entered into the study. Therefore this method of allocation concealment was considered to have low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: “The investigators and the patients were blinded to the treatment given, until the end of the study.”

Comment: double‐blind; therefore low risk of bias.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: “5 cases were lost to follow‐up (2 in the control group and one in each of the other three groups).”

Comment: Owing to the small number of participants lost to follow‐up, risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

High risk

No quotes available.

Comment: Primary outcomes were not prespecified; therefore risk of reporting bias was considered to be high.

Other bias

Low risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of other sources of bias was considered to be unclear.

Methods

• Study design: RCT.

• Study duration: not described.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: Turkey.

• Setting: not described.

• Patients with distal third ureteral stones 4‐10 mm.

• Number: treatment group: 37; control group: 34.

• Mean age ± SD, years: not described.

• Sex, M/F: not described.

• Exclusion criteria: not described.

Interventions

Group 1: tamsulosin group.

Group 2: corticosteroid group.

Group 3: tamsulosin and corticosteroid group.

Group 4: control group.

Data for groups 1 and 4 were used for the review.

Outcomes

• Stone expulsion rate.

• Need for surgical intervention.

• Drug adverse events.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Conference abstract.

Follow‐up on weekly basis with imaging (not discussed in detail).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: “A total of 134 patients with distal ureteral stone of 4‐10 mm were randomized into 4 groups.”

Comment: Randomisation stated but no information on method used was available; therefore selection bias was considered to be at unclear risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to be at unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

High risk

No quotes available. 6 patients in control group lost to follow‐up.

Comment: losses to follow‐up not balanced between treatment groups; therefore risk of attrition bias was considered to be high.

Selective reporting (reporting bias)

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of reporting bias was considered to be unclear.

Other bias

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of other sources of bias was considered to be unclear.

Methods

• Study design: RCT.

• Study duration: December 2004 to November 2005.

• Follow‐up/Treatment duration: maximum 3 weeks.

Participants

• Country: Turkey.

• Setting: single centre.

• Patients with distal ureteral stones < 10 mm.

• Number: treatment group 1: 30; treatment group 2: 30; treatment group 3: 30; control group: 30.

• Mean age (range, years): treatment group 1: 32.7 (19‐41); treatment group 2: 35.8 (22‐48); treatment group 3: 34.7 (24‐49); control group: 31.4 (20‐51).

• Sex, M/F: treatment group 1: 21/9; treatment group 2: 17/13; treatment group 3: 13/17; control group: 19/11.

• Exclusion criteria: severe hydronephrosis; a solitary kidney; an extra stone in the upper urinary system; underwent previous surgery for a urinary system stone; a non‐opaque stone; diseases such as diabetes or hypertension; pregnant; renal reserve reduced by > 50%.

Interventions

Treatment group 1:

• Tamsulosin 0.4 mg daily.

Treatment group 2:

• Tamsulosin 0.4 mg daily.

• Tolterodine 2 mg, twice daily.

Treatment group 3:

• Tolterodine 2 mg, twice daily.

Control group:

• No medical treatment.

All participants were treated with prophylactic antibiotic therapy (cefuroxime axetil 250 mg (once a day)) and received 2500 mL hydration daily.

Outcomes

• Stone expulsion rate.

• Stone expulsion time.

• VAS.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Weekly checkups and follow‐up with renal ultrasonography, complete urinalysis, serum urea creatinine measurements, and direct urinary system graphics.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: “After randomization to one of four groups, the patients received treatment.”

Comment: Owing to insufficient information, random sequence generation was considered to be at unclear risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to be at unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available. 5 participants were lost to follow‐up; they were included in the analysis.

Comment: Owing to the small number of participants lost to follow‐up, risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: January 2014 and January 2015.

• Follow‐up/Treatment duration: maximum 4 weeks.

Participants

• Country: Turkey.

• Setting: single centre.

• Patients with ureteral stones 5‐10 mm.

• Number: treatment group: 60; control group: 60.

• Mean age ± SD, years: control group: 37.23 ± 1.56; tamsulosin group: 37.07 ± 2.26.

• Sex, M/F: 84/36.

• Exclusion criteria: multiple stones; previous stone‐related procedures; obstruction; stent placement; congenital anomalies; active UTI; pregnancy; renal insufficiency; urgent stone removal and/or auxiliary procedures for intractable pain; obstruction; infection and other related complications during follow‐up period.

Interventions

Control group

• Diclofenac sodium 75 mg on demand.

Tamsulosin group

• Tamsulosin 0.4 mg.

• Diclofenac sodium 75 mg on demand.

Outcomes

• Stone passage rate.

• Analgesics required.

• Need for stone removal procedures.

• Number of renal colics.

• Number of ED visits.

• HRQOL.

• VAS scores during pain.

Funding sources

None.

Declarations of interest

None.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “simple randomization method by generating a random digit (0–60 in each group) has been used within each group.”

Comment: This method of random sequence generation was considered to be at low risk of bias.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, risk of allocation concealment was considered to be unclear.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No quotes available.

Comment: Losses to follow‐up were not clearly described; therefore risk of attrition bias was considered to be unclear.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: August 2006 to November 2007.

• Follow‐up/Treatment duration: 14 days.

Participants

• Country: USA.

• Setting: ED/single centre.

• Patients > 18 years, CT‐confirmed single distal ureteral stone.

• Number: treatment group: 39; control group: 41.

• Mean age ± SD, years: treatment group: 47 ± 14; control group: 45 ± 12.

• Sex, M/F: treatment group: 32/6; control group: 24/15.

• Exclusion criteria: allergy or sensitivity to study drug (tamsulosin hydrochloride); sulfa/sulfonamide allergy; lithiasis of ureteral intramural tract; AKI or CKD; fever; presence of multiple ureteral stones; peptic ulcer disease; liver failure; pregnancy; breastfeeding; history of urinary surgery; history of endoscopic treatment; concomitant treatment with any of the following pharmaceuticals: ‐lytic drugs, calcium channel antagonists, nitrates, and vardenafil hydrochloride; inability to use study pain scale; inability to read, write, and speak English.

Interventions

Treatment group

• Tamsulosin 0.4 mg daily for 10 days.

• Standard analgesic therapy.

Control group

• Standard analgesic therapy

  • Ibuprofen: 800 mg orally, 3 times daily.

  • Oxycodone: 5 to 10 mg orally, every 4 to 6 hours as needed for pain.

Outcomes

• Spontaneous passage rate.

• Stone expulsion time.

• Number of episodes of colicky pain.

• Number of return visits to the ED or unscheduled primary care visits.

• Amount of opioid analgesic used.

• Number of days of missed work or inability to perform usual functions.

• Adverse events.

• Self‐reported pain scores.

Funding sources

This study was funded by an academic grant from the Maine Medical Center Mentored Research Committee.

Declarations of interest

None stated.

Notes

Follow‐up with all participants at 2, 5, and 14 days post discharge from the ED.

Sample size calculated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: “Randomization was accomplished by using a table of random numbers.”

Comment: This method of random sequence generation was considered to be at low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: “The information on group assignment was contained in a sealed envelope within each study packet, and the envelopes were clearly labelled “do not open until informed consent is obtained.”

Comment: This method of allocation concealment was considered to be at low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available. Participants lost to follow‐up (4), discontinued intervention (2), excluded because the stone was located in the proximal ureter (1).

Comment: Losses to follow‐up were balanced across treatment groups; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: multi‐centre, randomised DB placebo‐controlled trial.

• Study duration: October 2010 until March 2014.

• Follow‐up/Treatment duration: 28 days.

Participants

• Country: Australia.

• Setting: emergency departments.

• Patients 18 years or older with symptoms suggestive of ureteric colic and a calculus demonstrated in the distal ureter on CT scan.

• Number: treatment group: 202; placebo group: 201.

• Median age, years (IQR): treatment group: 45.5 (35‐55); placebo group: 46 (37‐55).

• Sex: treatment group: 78.8% men; placebo group: 84.1% men.

• Exclusion criteria: temperature > 38 degrees C; estimated GFR less than 60 mL/min per 1.73 m²; calculus greater than 10 mm; solitary kidney; transplanted kidney; history of ureteral stricture; known allergic reaction to study medication; current calcium channel blocker or alpha‐blocker use; hypotension (systolic blood pressure < 100 mm Hg); pregnancy; planning pregnancy.

Interventions

Treatment group

• Tamsulosin 0.4 mg daily.

• Recommended regimen: indomethacin 25 to 50 mg 3 times daily orally and oxycodone 5 to 10 mg 3 times daily.

Placebo group

• Placebo drug.

• Recommended regimen: indomethacin 25 to 50 mg 3 times daily orally and oxycodone 5 to 10 mg 3 times daily.

Analgesia was given at the discretion of the treating physician.

Outcomes

• Stone expulsion rate.

• Stone expulsion time.

• Unplanned re‐presentations to the ED or hospital admission.

• Total analgesia requirements.

• Pain scores measured on the verbal numerical pain scale.

• Need for urological intervention.

• Complications including infection, renal impairment, and days off work.

• Adverse events from study drugs.

Funding sources

Grant from the Queensland Emergency Medicine Research Foundation.

Declarations of interest

None stated.

Notes

Power calculation was performed. Intention‐to‐treat‐principle.

Telephone contacts at 7, 14, 21, and 28 days with pelvic non‐contrast CT at day 28.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The randomization sequence was produced with a computer‐generated program in permuted blocks of random lengths stratified by hospital and stone size."

Comment: This method of random sequence generation was considered to be at low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: "Once informed consent was obtained and patients were deemed appropriate for discharge, they were allocated to the next sequentially numbered study medication pack."

Comment: This method of allocation concealment was considered to be at low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Quote: "Investigators, the treating physician, and patients were blinded to the allocation for the duration of the study and data analysis."

Comment: double‐blind; therefore low risk of bias.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote: “Investigators, the treating physician, and patients were blinded to the allocation for the duration of the study and data analysis.”

Comment: Personnel responsible for outcome assessments were blinded; therefore risk of detection bias was considered to be low.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "Similar proportions of patients with missing and nonmissing outcome data."

Comment: Missing outcome data were balanced in numbers across both groups, and reasons for missing data were similar; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: randomised prospective trial.

• Study duration: February 2013 and December 2013.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: Romania.

• Setting: single centre.

• Patients 18 years or older with unilateral, non‐impacted, uncomplicated ureteral stones smaller than 1 cm.

• Number: treatment group 1: 50; treatment group 2: 50; control group: 50.

• Mean age ± SD, years: treatment group 1: 43.5 ± 13.31; treatment group 2: 44.26 ± 13.00; control group: 45.14 ± 11.58.

• Sex, M/F: treatment group 1: 27/23; treatment group 2: 31/19; control group: 26/24.

• Exclusion criteria: fever; UTI; high‐grade hydronephrosis; hypotension; acute or chronic renal failure; single kidney; urinary congenital anomalies; multiple or bilateral ureteral stones; history of open surgery or endoscopic procedures in the urinary tract; diabetes; peptic ulcer; concomitant treatment with alpha‐ or beta‐blockers, calcium antagonists, steroid, nitrates; pregnant or lactating women; patients requiring immediate stone removal.

Interventions

Treatment group 1

• Tamsulosin 0.4 mg daily.

• Diclofenac sodium 50 mg/12 h.

Treatment group 2

• Silodosin 8 mg daily.

• Diclofenac sodium 50 mg/12 h.

Control group

• Diclofenac sodium 50 mg/12 h.

Outcomes

• Stone expulsion rate.

• Stone expulsion time.

• Mean number of pain episodes.

• Rates of interventions/Hospital re‐admissions.

• Drug adverse events.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Follow‐up at 14 ± 2 days with urinalysis, KUB, and ultrasonography.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "The randomization process was achieved by means of sealed envelopes equally nominating one of the three treatment alternative."

Comment: This method of random sequence generation was considered to be at low risk of bias.

Allocation concealment (selection bias)

Low risk

Quote: "Allocation concealment was performed using the SNOSE method (sequentially‐numbered, opaque, sealed envelopes)."

Comment: This method of allocation concealment was considered to be at low risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

Low risk

No quotes available. Expected outcomes were reported according to objectives.

Comment: Risk of reporting bias was therefore considered to be low.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.
Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: randomised prospective trial.

• Study duration: unknown.

• Follow‐up/Treatment duration: 4 weeks.

Participants

• Country: India.

• Setting: single centre.

• Patients 18 years or older with unilateral distal ureteral stones measuring 4‐10 mm.

• Number: treatment group: 30; control group: 30.

• Mean age ± SD, years: treatment group: 34.20 ± 13.96; control group: 36.00 ± 12.22.

• Sex, M/F: treatment group 2: 19/11; control group: 18/12.

• Exclusion criteria: all cases having active urinary tract infection; fever; acute renal failure; chronic renal failure; history of urinary surgery or endoscopic treatment; uncorrected distal obstruction; marked hydronephrosis.

Interventions

Treatment group

• Tamsulosin 0.4 mg daily

Control group

• Both groups received diclofenac 50 mg and Buscopan 10 mg orally on demand.

Outcomes

Successful results were defined as complete stone passage; failure was considered if:

• the participant failed to pass the stone at the end of 28 days; or

• uncontrolled pain and/or uroseptic fever led to hospitalisation during the study period.

Funding sources

None.

Declarations of interest

None.

Notes

Follow‐up weekly with KUB.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "... were divided randomly."

Comment: Randomisation stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to be at unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No quotes available.

Comment: All participants completed the study; therefore risk of attrition bias was considered to be low.

Selective reporting (reporting bias)

High risk

No quotes available.

Comment: Outcomes were not prespecified; therefore risk of reporting bias was considered to be high.

Other bias

Low risk

No quotes available. Study appears to be free of other sources of bias.

Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low.

Methods

• Study design: RCT.

• Study duration: NS.

• Follow‐up/Treatment duration: 28 days.

Participants

• Country: Korea.

• Setting: NS.

• Patients with stones < 5 mm that were located in the lower ureter.

• Number: treatment group: 35; control group: 32.

• Mean age ± SD, years: NS.

• Sex, M/F: NS.

• Exclusion criteria: UTI; hydronephrosis; pregnancy; diabetes; multiple stones; low blood pressure.

Interventions

Treatment group

• Tamsulosin 0.2 mg orally once daily.

Control group

• Caroverine (a spasmolytic drug): 20 mg orally 3 times daily.

All participants were allowed 30 mg ketorolac IM injections on demand.

Outcomes

• Stone expulsion rate.

• Stone expulsion time.

• Use of analgesics.

Funding sources

None stated.

Declarations of interest

None stated.

Notes

Only English abstract available for judgement.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No quotes available.

Comment: randomisation stated but no information on method used was available; therefore risk of selection bias was considered to be unclear.

Allocation concealment (selection bias)

Unclear risk

No quotes available. Insufficient information to permit judgement.

Comment: Owing to insufficient information, allocation concealment was considered to have unclear risk of bias.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No quotes available. No blinding described.

Comment: Owing to insufficient information, risk of performance bias was considered to be unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No quotes available. No blinding of outcome assessments described.

Comment: Owing to insufficient information, risk of detection bias was considered to be unclear.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No quotes available.

Comment: Losses to follow‐up were not clearly described; therefore risk of attrition bias was considered to be unclear.

Selective reporting (reporting bias)

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of reporting bias was considered to be unclear.

Other bias

Unclear risk

No quotes available.

Comment: Owing to insufficient information to permit judgement, risk of other sources of bias was considered to be unclear.

Methods

• Study design: :double‐blind RCT.

• Study duration: September 2006 to September 2008.

• Follow‐up/Treatment duration: 21 days.

Participants

• Country: Switzerland.

• Setting: outpatient, single centre.

• Patients ≥ 18 years with single ureteral stone ≤ 7 mm below the common iliac vessels, as assessed on NCCT.

• Number: treatment group: 50; control group: 50.

• Median age, years (IQR): treatment group: 36 (30–44); control group: 41 (33–54).

• Sex, M/F: treatment group: 39/6; control group: 36/9.

• Exclusion criteria: presence of multiple ureteral stones; renal insufficiency (eGFR < 60 mL/min/1.73 m²); UTI; a solitary kidney; pregnancy; history of ureteral surgery or previous endoscopic procedures; hypersensitivity to tamsulosin or current alpha‐blocker, calcium antagonist, or corticosteroid medication.

Interventions

Treatment group

• Tamsulosin 0.4 mg once daily.