Scolaris Content Display Scolaris Content Display

La función de los alfabloqueantes antes de la retirada de la sonda urinaria para la retención urinaria aguda en los hombres

Contraer todo Desplegar todo

Referencias

Referencias de los estudios incluidos en esta revisión

Agrawal 2009 {published data only}

Agrawal MS, Yadav A, Yadav H, Singh AK, Lavania P, Jaiman R. A prospective randomized study comparing alfuzosin and tamsulosin in the management of patients suffering from acute urinary retention caused by benign prostatic hyperplasia. Indian Journal of Urology 2009;25(4):474‐8.

Hua 2003 {published data only}

Hua LX, Wu HF, Sui YG, Chen SG, Xu ZQ, Zhang W, et al. [Tamsulosin in the treatment of benign prostatic hyperplasia patients with acute urinary retention]. [Chinese]. Zhong Hua Nan Ke Xue 2003;9(7):510‐1. [23479]

Kumar 2013 {published data only}

Kumar S, Tiwari PD, Ganesamoni R, Singh SK. Prospective randomized placebo‐controlled study to assess the safety and efficacy of silodosin in the management of acute urinary retention. Urology 2013;82(1):171‐5.

Lucas 2005 {published data only}

Lucas MG, Stephenson TP, Nargund V. Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia. BJU International 2005;95(3):354‐7. [23750]

McNeill 1999 {published data only}

McNeill SA, Daruwala PD, Mitchell ID, Shearer MG, Hargreave TB. Sustained‐release alfuzosin and trial without catheter after acute urinary retention: a prospective, placebo‐controlled. [comment]. BJU International 1999;84(6):622‐7.

McNeill 2005 {published data only}

Annemans L, Cleemput I, Lamotte M, McNeill A, Hargreave T. The economic impact of using alfuzosin 10 mg once daily in the management of acute urinary retention in the UK: a 6‐month analysis. BJU International 2005;96:566‐71.
McNeill SA, Hargreave TB, Members of the Alfaur Study Group 2004. Alfuzosin once daily facilitates return to voiding in patients in acute urinary retention. Journal of Urology 2004;171(6 Pt 1):2316‐20.
McNeill SA, Hargreave TB, Roehrborn CG, Alfaur Study Group 2005. Alfuzosin 10 mg once daily in the management of acute urinary retention: results of a double‐blind placebo‐controlled study. Urology 2005;65(1):83‐9, discussion 89‐90.

Prieto 2008 {published data only}

Prieto L, Romero J, Lopez C, Ortiz M, Pacheco JJ. Efficacy of doxazosin in the treatment of acute urinary retention due to benign prostate hyperplasia. Urologia Internationalis 2008;81(1):66‐71.

Shah 2002 {published data only}

Shah T, Palit V, Biyani S, Elmasry Y, Puri R, Flannigan GM. Randomised, placebo controlled, double blind study of alfuzosin SR in patients undergoing trial without catheter following acute urinary retention. European Urology 2002;42(4):323‐32.

Tiong 2009 {published data only}

Tibung MJB, Tiong HY, Macalalag M, Liew L, Li MK. Alfuzosin XL prior to trial off catheter after acute urinary retention: early results from a randomized, double‐blinded, placebo‐controlled trial. International Journal of Urology 2006;13 Suppl 1:35.
Tiong HY, Tibung MJ, Macalalag M, Li MK, Consigliere D. Alfuzosin 10 mg once daily increases the chances of successful trial without catheter after acute urinary retention secondary to benign prostate hyperplasia. Urologia Internationalis 2009;83(1):44‐8.

Referencias de los estudios excluidos de esta revisión

Joo 2008 {published data only}

Joo KJ, Choi JB, Kim YS, Kim H, Park HS, Lee W, et al. Effect of tamsulosin in benign prostatic hyperplasia patients who were treated with spinal anesthesia: preventing the acute urinary retention (Abstract number 294). Proceedings of the 38th Annual Meeting of the International Continence Society (ICS), 2008 Oct 20‐24, Cairo, Egypt. 2008.

Kraus 2010 {published data only}

Kraus SR, Dmochowski R, Albo ME, Xu L, Klise SR, Roehrborn CG. Urodynamic standardization in a large‐scale, multicenter clinical trial examining the effects of daily tadalafil in men with lower urinary tract symptoms with or without benign prostatic obstruction. Neurourology & Urodynamics 2010;29(5):741‐7.

Lim 1999 {published data only}

Lim KB, Wong MY, Foo KT. The outcome of trial off catheter after acute retention of urine. Annals of the Academy of Medicine, Singapore 1999;28(4):516‐8.

Liu 2009 {published data only}

Liu H, Liu P, Mao G, Chen G, Wang B, Qin X, et al. Efficacy of combined amlodipine/terazosin therapy in male hypertensive patients with lower urinary tract symptoms: a randomized, double‐blind clinical trial. Urology 2009;74(1):130‐6.

Lorente 2004 {published data only}

Lorente Garin JA, Canis SD, Arango TO, Bielsa GO, Cortadellas AR, Gelabert MA. [Doxazosin in the gastrointestinal therapeutic system (GITS) formulation and trial without catheter after acute urinary retention due to BPH. Dose increase action on recovery effect]. [Spanish]. Actas Urologicas Espanolas 2004;28(1):32‐7. [MEDLINE: 23480]

Martov 2010 {published data only}

Martov AG, Maksimov VA, Ergakov DV, Miroshnikov VM, Asfandiiarov FR, Kalashnikov ES. [Tamsulosin administration for prophylaxis and treatment of stent‐related symptoms] [Russian]. Urologiia (Moscow, Russia) 2010 Jan‐Feb;.(1):3‐8.

McNeill 2004 {published data only}

McNeill AS, Rizvi S, Byrne DJ. Prostate size influences the outcome after presenting with acute urinary retention. BJU International 2004;94(4):559‐62.

Taube 1989b {published data only}

Taube M, Gajraj H. Trial without catheter following acute retention of urine [see comments]. British Journal of Urology 1989;63(2):180‐2.

Wang 2009 {published data only}

Wang CJ, Huang SW, Chang CH. Effects of tamsulosin on lower urinary tract symptoms due to double‐J stent: a prospective study. Urologia Internationalis 2009;83(1):66‐9.

Referencias de los estudios en espera de evaluación

Perepanova 2001 {published data only}

Perepanova TS, Kamalov AA, Sinyuhin VN, Gorohov AV, Hazan PL, Orlov EV. Doxazosin (Kardura) with acute urinary retention due to benign prostatic hyperplasia. Urologiia 2001;3:18‐20.

Annemans 2005

Annemans L, Cleemput I, Lamotte M, McNeill A, Hargreave T. The economic impact of using alfuzosin 10 mg once daily in the management of acute urinary retention in the UK: a 6‐month analysis. BJU International 2005;96:566‐71.

Barry 1997

Barry MJ, Fowler Jr FJ, Bin L, Pitts III JC, Harris CJ, Mulley Jr AG. The natural history of patients with benign prostatic hyperplasia as diagnosed by North American urologists. Journal of Urology 1997;157:10‐4, discussion 14‐5.

Batista‐Miranda 1995

Batista‐Miranda JE, Regalado Pareja R, Huguet Pérez J, Montlleo Sánchez M, Araño Bertran P. The use of the IPSS questionnaire in surgical patients. International Prostatic Symptom Score. Actas Urol Esp 1995;19(3):227‐33.

Bird 2013

Bird ST, Delaney JA, Brophy JM, Etminan M, Skeldon SC, Hartzema AG. Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40‐85 years in the United States: risk window analyses using between and within patient methodology. BMJ 2013;347(5):f6320. [DOI: http://dx.doi.org/10.1136/bmj.f6320]

BNF December 2013

Joint Formulary Committee. British National Formulary December 2013. London: Published jointly by BMJ Group and Pharmaceutical Press, 2013. Available at: http://www.bnf.org.

Caine 1975

Caine M, Raz S, Ziegler M. Adrenergic and cholinergic receptors in the human prostate capsule and bladder neck. British Journal of Urology 1975;47:193.

Caine 1976

Caine M, Pfau A, Perlberg S. The use of alpha‐adrenergic blockers in benign prostatic obstruction. British Journal of Urology 1976;48:255‐63.

Caine 1987

Caine M, Schuger L. The capsule in benign prostatic hypertrophy. Department of Health and Human Services, National Institute of Health Publication 1987;87‐2881:221.

Emberton 1999

Emberton M, Anson K. Acute urinary retention in men: an age old problem. BMJ 1999;318:921‐5.

Fulton 1995

Fulton B, Wagstaff AJ, Sorkin EM. Doxazosin. An update of its clinical pharmacology and therapeutic applications in hypertension and benign prostatic hyperplasia. Drugs 1995;49:295‐320.

Guyatt 2011

Guyatt GH, Oxman AD, Schunemann HJ, Tugwell P, Knottnerus A. GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology. Journal of Clinical Epidemiology 2011;64(4):380‐2.

Guyatt 2011a

Guyatt GH, Oxman AD, Sultan S, Glasziou P, Akl EA, Alonso‐Coello P, et al. GRADE guidelines: 9. Rating up the quality of evidence. Journal of Clinical Epidemiology 2011;64(12):1311‐6.

Guyatt 2013a

Guyatt GH, Oxman AD, Santesso N, Helfand M, Vist G, Kunz R, et al. GRADE guidelines: 12. Preparing Summary of Findings tables‐binary outcomes. Journal of Clinical Epidemiology 2013;66(2):158‐72.

Guyatt 2013b

Guyatt GH, Thorlund K, Oxman AD, Walter SD, Patrick D, Furukawa TA, et al. GRADE guidelines: 13. Preparing Summary of Findings tables and evidence profiles‐continuous outcomes. Journal of Clinical Epidemiology 2013;66(2):173‐83.

Haylen 2010

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics 2010;29:4‐20.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Jacobsen 1997

Jacobsen SJ, Jacobsen DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA. Natural history of prostatism: risk factors for acute urinary retention. Journal of Urology 1997;158:481‐7.

Lamotte 2005

Lamotte M, Annemans L, Lamberts G, Michielsen D, Nicolas H, Van Cangh P, et al. The cost of complicated acute urinary retention: a patient chart analysis in Belgium]. Revue Medicale de Liege 2005;60(11):875‐81.

McConnell 1998

McConnel JD, Bruskewitz R, Walsh P, Andriole G, Lieber M, Holtgrewe HL, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride long‐term efficacy and safety study group. New England Journal of Medicine 1998;338:557‐63.

Meigs 1999

Meigs JB, Barry MJ, Giovannucci E, Rimm EB, Stampfer MJ, Kawachi I. Incidence rates and risk factors for acute urinary retention: the health professionals followup study. Journal of Urology 1999;162:376‐82.

Murray 1984

Murray K, Massey A, Feneley RC. Acute urinary retention ‐ a urodynamic assessment. British Journal of Urology 1984;56:468‐73.

Niël‐Weise 2005

Niël‐Weise BS, van den Broek PJ. Urinary catheter policies for long‐term bladder drainage. Cochrane Database of Systematic Reviews 2005, Issue 1. [DOI: 10.1002/14651858.CD004201.pub2]

Omar 2014

Omar MI, Lam TB, Alexander CE, Graham J, Mamoulakis C, Imamura M, et al. Systematic review and meta‐analysis of the clinical effectiveness of bipolar compared with monopolar transurethral resection of the prostate (TURP). BJU International2014; Vol. 113, issue 1:24–35. [DOI: 10.1111/bju.12281]

Pickard 1998

Pickard R, Emberton M, Neal DE. The management of men with acute urinary retention. British Journal of Urology 1998;81:712‐20.

Ramirez 2013

Ramirez J. Severe hypotension associated with α blocker tamsulosin. BMJ 2013;347:f6492. [DOI: http://dx.doi.org/10.1136/bmj.f6492]

Ramirez 2014

Ramirez J. Expression of concern about tamsulosin: over three quarters of human studies are unpublished. figshare2014. [DOI: http://dx.doi.org/10.6084/m9.figshare.1094338]

Reference Manager 2012

Reference Manager Professional Edition Version 12. New York: Thomson Reuters2012.

Roerborn 2000

Roehrborn CG, Bruskewitz R, Nickel GC, Glickman S, Cox C, Anderson R, et al. Urinary retention in patients with BPH treated with finasteride or placebo over 4 years. Characterization of patients and ultimate outcomes. The PLESS study group. European Urology 2000;37:528‐36.

Schulman 2001

Schulman CC. Long‐term aspects of medical treatment of BPH. European Urology 2001;40 Suppl 3:8‐12.

Taube 1989a

Taube M, Gajraj H. Trial without catheter following acute retention of urine. British Journal of Urology 1989;63(2):180‐2.

Temml 2003

Temml C, Brossner C, Schatzl G, Ponholzer A, Knoepp L, Madersbacher S. The natural history of lower urinary tract symptoms over five years. European Urology 2003;43:374‐80.

Thomas 2005

Thomas K, Oades G, Taylor‐Hay C, Kirby RS. Acute urinary retention: what is the impact on patients' quality of life?. British Journal of Urology International 2005;95(1):72‐6.

Verhamme 2005

Verhamme KM, Dieleman JP, van Wijk MA, Bosch JL, Stricker BH, Sturkenboom MC. Low incidence of acute urinary retention in the general male population: the triumph project. European Urology 2005;47(4):494‐8.

Referencias de otras versiones publicadas de esta revisión

Zeif 2009

Zeif HJ, Subramonian K. Alpha blockers prior to removal of a catheter for acute urinary retention in adult men. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD006744.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Agrawal 2009

Methods

Prospective, randomised, placebo‐controlled, single centre study

Participants

150 patients ( 50 alfuzosin, 50 tamsulosin, 50 placebo), mean age 69, 72 and 71 years respectively (aged 48 to 90 years)

Interventions

A (50): Alfuzosin 10 mg OD

B (50): Tamsulosin 0.4 mg

C (50): Placebo,

Then TWOC after 3 days

Outcomes

Number who had successful TWOC: A 33/50, B   35/50, C 18/50

Initial catheterisation volume

American Urological Association score

Post void residual urinary volume (mL)

Peak urinary flow rate (mL/sec)

Adverse effects

Notes

Second trial phase: successful TWOC patients continued in respective treatment groups and followed up at 1 week, 2 weeks, 1 month and 3 months.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method of randomisation not specified: '...randomized into three groups.'

Allocation concealment (selection bias)

Unclear risk

Not specified

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

More detail in tables of analysis needed.

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not specified

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

Unclear risk

Other aspects of trial design such as baseline comparability, sample size calculation, use of intention‐to‐treat analysis and financial support were inadequately or not at all specified.

Hua 2003

Methods

Prospective, randomised single centre study

Participants

72 patients (36 tamsulosin, 36 no treatment)

Interventions

A (36): Tamsulosin 0.4 mg once daily for three days

B (36): No treatment, TWOC after 3 days (both groups given prophylactic antibiotics)

Outcomes

TWOC success rates:A 22/36 , B 10/36

Notes

Full text article in Chinese with English abstract. TWOC success rates stated in English abstract but no other usable data available for any of the specified outcomes.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'...were randomly divided into treatment group and control group of 36 patients each.'

Allocation concealment (selection bias)

Unclear risk

Not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No incomplete data

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not specified

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

Unclear risk

Other aspects of trial design such as baseline comparability, sample size calculation and financial support not specified.

Kumar 2013

Methods

Prospective, randomised placebo‐controlled single centre study

Participants

60 patients (30 silodosin, 30 placebo).

Mean age (SD):

  • Group A: 64.5 (9.3)

  • Group B: 65.8 (8.1)

Interventions

A (30): Silodosin 8 mg once daily for 3 days

B (30): placebo

Outcomes

Number who had successful TWOC: A 23/30, B 11/30

Factors influencing TWOC failure

Effects of silodosin on uroflowmetry and IPSS in patients who had successful TWOC

Notes

Study conducted in tertiary care regional referral centre in Northern India

Successful TWOC:

  • ‘If the patient voided successfully, a postvoid bladder scan was performed to measure his residual urine volume.  If there was less than 150 mL postvoid residual volume after voiding at least 100 mL of urine, he was considered to have a successful TWOC.’

Failed TWOC:

  • ‘...if the patient re‐experienced painful AUR or if the PVR urine volume was >150 mL, he was re‐catheterised and considered to have a failed TWOC.’

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

‘...centrally established computer‐assigned randomization list...’

Allocation concealment (selection bias)

Unclear risk

Not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No incomplete outcome data

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Placebo administered was ‘similar to silodosin capsule in colour, weight, and shape’

Unclear if personnel were blinded.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

Low risk

Study groups were comparable at baseline

Power calculation was performed

Ethical approval obtained

Written informed consent obtained

No withdrawals/loss to follow‐up

Lucas 2005

Methods

Randomised, double‐blind, placebo‐controlled, parallel‐group, multicentre study

Participants

149 patients (75 tamsulosin, 74 placebo), mean age 69.4 years

Interventions

A (75): Tamsulosin 0.4mg once daily

B (74): Placebo

TWOC 'after up to 8 doses'

Outcomes

Number who had successful TWOC: A 34/75, B 18/74

Notes

Qmax, PVR volume and spontaneously voided volume analysed but not separately (in groups of 'any two successful criteria')

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'...randomized, double‐blind, placebo‐controlled, parallel‐group, multicentre study'

Allocation concealment (selection bias)

Unclear risk

Not specified ('...randomly assigned to receive...')

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No incomplete data

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Double blinded

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

High risk

'This study was sponsored by a grant from Yamanouchi Pharma Ltd.'

McNeill 1999

Methods

Prospective, randomised, placebo‐controlled multicentre trial

Participants

81 patients (40 alfuzosin, 41 placebo), mean age 68.4 years

Interventions

A(40): Alfuzosin SR 5 mg twice daily

B (41): Placebo

TWOC after 24 hours

Outcomes

Number who had successful TWOC: A 22/40, B 12/41

Factors affecting successful TWOC

Incidence of adverse events

Incidence of repeat episode of AUR in patients who had successful TWOC

Need for surgery in patients who had successful TWOC

Notes

Allocation concealment well explained

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'...tablets was allocated a study number generated randomly by computer'

Allocation concealment (selection bias)

Low risk

'A sealed copy of the code was held by each participating pharmacy, ...'

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No incomplete data.

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Double blinded.

'A central pharmacy...packaged the SR alfuzosin and placebo to appear identical...'

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified if assessors were blinded at time of TWOC.

Other bias

High risk

High risk:

  • Baseline comparability: 'The mean age was five years lower in the SR alfuzosin group than in the placebo group (P = 0.049).'

  • Sample size calculation: 'The initial intention was to recruit 100 patients to each arm of the trial, to detect a 20% difference in outcome with 95% power, but such numbers could not be recruited before the trial medication expired'.

  • Financial support was obtained from Lorex Synthélabo UK & Ireland.

Low risk:

  • Ethical approval and informed consent obtained.

  • Data were analysed on an intention‐to‐treat basis

McNeill 2005

Methods

Randomised, double‐blind, placebo‐controlled multicentre trial

Participants

363 patients randomised (A 238, B 122. See notes)

Interventions

A (238): Alfuzosin 10 mg once daily

B (122): Placebo

Then TWOC after 3 days

Outcomes

Number who had successful TWOC: A 146/236, B 58/121

Factors influencing TWOC success

Notes

Second phase of trial: successful TWOC patients again randomised into alfuzosin versus placebo for 6 months (AUR relapse/ BPH surgery need). Data missing for 3 patients therefore results for primary outcome were reported as sub‐totals without these patients (A 236, B 121). Adverse events were however reported as sub‐totals including these patients (A 238, B 122)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Patients were randomized...according to a centrally established randomization list.'

Allocation concealment (selection bias)

Unclear risk

Not explained

Incomplete outcome data (attrition bias)
All outcomes

High risk

Incomplete data for 3 patients

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Double blinded

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

High risk

High risk:

  • Funding obtained from Sanofi‐Aventis

  • Results reported as either intention‐to‐treat or per‐protocol without justification for change.

Low risk:

  • Ethical approval and informed consent obtained

Prieto 2008

Methods

Randomised, controlled single centre study

Participants

46 patients (23 doxazosin, 23 no treatment), mean age 74 years

Interventions

A (23): Doxazosin modified release 4 mg once daily

B (23): No treatment

TWOC on day 32.

Outcomes

TWOC success rates: A 13/22, B 13/24

Maximum urinary flow rate in patients with spontaneous micturition

Post‐void residual volume in patients with spontaneous micturition

Notes

Second phase trial: successful TWOC patients review at 6, 12 and 24 months for recurrence of AUR

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

'Two groups were formed.' Patients 'born in even‐numbered years' (doxazosin group) versus 'born in odd‐numbered years' (no treatment group)

Allocation concealment (selection bias)

High risk

Patients 'born in even‐numbered years' (doxazosin group) versus 'born in odd‐numbered years' (no treatment group)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No incomplete data

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding is unlikely given the study design.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

High risk

High risk:

  • Funding obtained from Pfizer.

  • Inconsistency in description of intervention for Group B; no medication versus placebo.

Low risk:

  • Ethical approval obtained

Shah 2002

Methods

Randomised, double‐blind, placebo‐controlled single centre study

Participants

62 patients (34 alfuzosin, 28 placebo), mean age 68.6 years

Interventions

A (34): Alfuzosin SR 5 mg twice daily versus

B (28): Placebo, TWOC after minimum of three doses or 36 hours after admission

Outcomes

TWOC success rates: A 17/34, B 16/28

Need for further TURP (phase 2)

Notes

Phase 2 of study; all patients with successful TWOC were given Alfuzosin SR 5 mg twice daily and followed up at 1 year and 2 years.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

'...double blind, placebo controlled study...'

'Patients were randomised to receive ...'

Allocation concealment (selection bias)

Unclear risk

Not specified

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No incomplete data

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Double blinded

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

High risk

Funding obtained from Lorex Synthelabo Pharma.

Tiong 2009

Methods

Prospectively, randomised trial single centre study

Participants

67 patients (35 alfuzosin, 32 placebo)

Interventions

A (35): Alfuzosin XL 10 mg once daily

B (32): Placebo

'...TWOC at least 2h after taking the second dose of trial medication.'

Outcomes

TWOC success rates: A (21/35), B (11/32)

Notes

Both patient groups offered alpha blocker treatment after successful TWOC

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomised '...using a centrally established computer‐assigned randomization list'.

Allocation concealment (selection bias)

Low risk

'The allocation and administration of treatment were double‐blinded'.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No incomplete data

Selective reporting (reporting bias)

Unclear risk

All the outcomes as detailed in the method section of the trial were reported in the result section. Some outcomes which are considered important from patients’ perspective were not reported. Without the protocol it was difficult to judge whether or not these outcomes were included in the protocol and not reported in the report.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

'The allocation and administration of treatment were double‐blinded'.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified

Other bias

Low risk

  • Groups comparable at baseline for all characteristics measured (except mean retention urine volume at initial catheterisation; borderline non‐significance [P = 0.06])

  • Ethical approval and informed consent obtained

  • Low withdrawal rate

AUR = acute urinary retention
BPH = benign prostatic hyperplasia
IPSS = International Prostate Symptom Score
PVR = post‐void residual
TURP = transurethral resection of the prostate
TWOC = trial without catheter
SD = standard deviation
SR = sustained release
XL = extended release

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Joo 2008

Tamsulosin versus no treatment for TWOC in spinal surgery patients electively catheterised perioperatively (not in acute urinary retention prior to surgery).

Kraus 2010

No catheters involved. Urodynamic assessment of daily tadalafil versus placebo on lower urinary tract symptoms.

Lim 1999

No alpha blockers used in study. Study describes outcome of TWOC in 79 untreated patients.

Liu 2009

No catheters involved as patients not in acute urinary retention. Randomised trial of amlodipine with or without terazosin for LUTS.

Lorente 2004

Use of increasing dosage of doxazosin in failed TWOC patients. 40 patients randomly assigned to doxazosin 4 mg once daily (n = 20) or no treatment (n = 20) for seven days before TWOC. Failed TWOC patients either received doxazosin 8mg (treatment group) or 4 mg (control group) once daily before a second TWOC.

Martov 2010

No catheters involved as study assessing tamsulosin for stent‐related irritative symptoms.

McNeill 2004

Long‐term follow‐up study of patient cohort who had successful TWOC following an episode of acute urinary retention (alfuzosin versus placebo).

Taube 1989b

No alpha‐blockers used in study. Study describes outcome of TWOC immediately, after 24 and 48 hours in 60 untreated patients (subdivided into three groups).

Wang 2009

No catheters involved as study assessing effect of tamsulosin in patients with indwelling double‐J ureteral stents.

LUTS = lower urinary tract symptoms
TWOC = trial without catheter

Characteristics of studies awaiting assessment [ordered by study ID]

Perepanova 2001

Methods

Prospective, randomised, controlled trial.

Participants

Patients admitted on an emergency basis with AUR due to benign prostatic hyperplasia.

Interventions

Group A: Doxazosin 4 mg

Group B: Placebo

Catheters removed after 12 hours.

Outcomes

Number with successful TWOC: A 19/30, B 1/6

Need for further surgery: A10/30, B 5/6

Notes

Paper translated from Russian.

Method of randomisation and allocation concealment unclear: 30 patients in Group A, 6 patients in Group B.

Which patient received which surgery unclear.

No statistical analysis was performed on outcomes.

AUR = acute urinary retention
TWOC = trial without catheter

Data and analyses

Open in table viewer
Comparison 1. Alpha blocker versus placebo or control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Ability to void spontaneously after TWOC without the need for re‐catheterisation Show forest plot

9

1094

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [1.36, 1.76]

Analysis 1.1

Comparison 1 Alpha blocker versus placebo or control, Outcome 1 Ability to void spontaneously after TWOC without the need for re‐catheterisation.

Comparison 1 Alpha blocker versus placebo or control, Outcome 1 Ability to void spontaneously after TWOC without the need for re‐catheterisation.

1.1 Alfuzosin versus control

5

667

Risk Ratio (M‐H, Fixed, 95% CI)

1.40 [1.19, 1.64]

1.2 Tamsulosin versus control

3

321

Risk Ratio (M‐H, Fixed, 95% CI)

1.97 [1.49, 2.59]

1.3 Doxazosin versus control

1

46

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.66, 1.81]

1.4 Silodosin versus control

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

2.09 [1.26, 3.48]

2 Incidence of recurrent urinary retention Show forest plot

8

1023

Risk Ratio (M‐H, Fixed, 95% CI)

0.69 [0.60, 0.79]

Analysis 1.2

Comparison 1 Alpha blocker versus placebo or control, Outcome 2 Incidence of recurrent urinary retention.

Comparison 1 Alpha blocker versus placebo or control, Outcome 2 Incidence of recurrent urinary retention.

2.1 Alfuzosin versus control

5

667

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.60, 0.85]

2.2 Tamsulosin versus control

2

249

Risk Ratio (M‐H, Fixed, 95% CI)

0.66 [0.50, 0.87]

2.3 Doxazosin versus control

1

47

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.65, 1.48]

2.4 Silodosin versus control

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.37 [0.18, 0.74]

3 Number with adverse effects due to alpha‐blocker treatment Show forest plot

5

1064

Risk Ratio (M‐H, Fixed, 95% CI)

1.19 [0.75, 1.89]

Analysis 1.3

Comparison 1 Alpha blocker versus placebo or control, Outcome 3 Number with adverse effects due to alpha‐blocker treatment.

Comparison 1 Alpha blocker versus placebo or control, Outcome 3 Number with adverse effects due to alpha‐blocker treatment.

3.1 Alfuzosin versus control

3

868

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.53, 1.54]

3.2 Tamsulosin versus control

1

149

Risk Ratio (M‐H, Fixed, 95% CI)

2.71 [0.90, 8.14]

3.3 Doxazosin versus control

1

47

Risk Ratio (M‐H, Fixed, 95% CI)

3.13 [0.13, 73.01]

4 Number with serious adverse effects due to alpha‐blocker treatment Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.4

Comparison 1 Alpha blocker versus placebo or control, Outcome 4 Number with serious adverse effects due to alpha‐blocker treatment.

Comparison 1 Alpha blocker versus placebo or control, Outcome 4 Number with serious adverse effects due to alpha‐blocker treatment.

4.1 Alfuzosin versus control

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Number of drop‐outs due to adverse effects of alpha blockers treatment Show forest plot

5

705

Risk Ratio (M‐H, Fixed, 95% CI)

3.94 [1.28, 12.12]

Analysis 1.5

Comparison 1 Alpha blocker versus placebo or control, Outcome 5 Number of drop‐outs due to adverse effects of alpha blockers treatment.

Comparison 1 Alpha blocker versus placebo or control, Outcome 5 Number of drop‐outs due to adverse effects of alpha blockers treatment.

5.1 Alfuzosin versus control

3

509

Risk Ratio (M‐H, Fixed, 95% CI)

2.83 [0.62, 12.93]

5.2 Tamsulosin versus control

1

149

Risk Ratio (M‐H, Fixed, 95% CI)

6.91 [0.87, 54.76]

5.3 Doxazosin versus control

1

47

Risk Ratio (M‐H, Fixed, 95% CI)

3.13 [0.13, 73.01]

PRISMA study flow diagram
Figuras y tablas -
Figure 1

PRISMA study flow diagram

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Alpha blocker versus placebo or control, Outcome 1 Ability to void spontaneously after TWOC without the need for re‐catheterisation.
Figuras y tablas -
Analysis 1.1

Comparison 1 Alpha blocker versus placebo or control, Outcome 1 Ability to void spontaneously after TWOC without the need for re‐catheterisation.

Comparison 1 Alpha blocker versus placebo or control, Outcome 2 Incidence of recurrent urinary retention.
Figuras y tablas -
Analysis 1.2

Comparison 1 Alpha blocker versus placebo or control, Outcome 2 Incidence of recurrent urinary retention.

Comparison 1 Alpha blocker versus placebo or control, Outcome 3 Number with adverse effects due to alpha‐blocker treatment.
Figuras y tablas -
Analysis 1.3

Comparison 1 Alpha blocker versus placebo or control, Outcome 3 Number with adverse effects due to alpha‐blocker treatment.

Comparison 1 Alpha blocker versus placebo or control, Outcome 4 Number with serious adverse effects due to alpha‐blocker treatment.
Figuras y tablas -
Analysis 1.4

Comparison 1 Alpha blocker versus placebo or control, Outcome 4 Number with serious adverse effects due to alpha‐blocker treatment.

Comparison 1 Alpha blocker versus placebo or control, Outcome 5 Number of drop‐outs due to adverse effects of alpha blockers treatment.
Figuras y tablas -
Analysis 1.5

Comparison 1 Alpha blocker versus placebo or control, Outcome 5 Number of drop‐outs due to adverse effects of alpha blockers treatment.

Summary of findings for the main comparison. Alpha blocker versus placebo or control for acute urinary retention in adult men

Alpha blocker versus placebo or control for acute urinary retention in adult men

Patient or population: acute urinary retention in adult men
Intervention: Aalpha blocker versus placebo or control

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Aalpha blocker versus placebo or control

Ability to void spontaneously after TWOC without the need for re‐catheterisation

Study population

RR 1.55
(1.36 to 1.76)

1044
(9 studies)

⊕⊕⊕⊝
moderate1,2

383 per 1000

582 per 1000
(509 to 666)

Incidence of recurrent urinary retention

Study population

RR 0.69
(0.60 to 0.79)

1023
(8 studies)

⊕⊕⊝⊝
moderate2,3

507 per 1000

350 per 1000
(304 to 400)

Need for prostatic surgerynot reported

See comment

See comment

Not estimable

See comment

Condition‐specific QoLnot reported

See comment

See comment

Not estimable

See comment

Cost effectivenessnot reported

See comment

See comment

Not estimable

See comment

Number with adverse effects

Study population

RR 1.2
(0.74 to 1.95)

657
(4 studies)

⊕⊕⊝⊝
low2,4

74 per 1000

89 per 1000
(55 to 145)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio; QoL: quality of life; TWOC: trial without catheter

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Random sequence generation unclear in 4 studies and high risk in 1 study. Allocation concealment unclear in 6 studies and high risk in 1 study.
2 A minimum of ten trials are required to assess for publication bias.
3 Random sequence generation unclear in 3 studies and high risk in 1 study. Allocation concealment unclear in 5 studies and high risk in 1 study.
4 Wide 95% confidence interval: RR 1.20 (95% CI 0.74 to 1.95)

Figuras y tablas -
Summary of findings for the main comparison. Alpha blocker versus placebo or control for acute urinary retention in adult men
Comparison 1. Alpha blocker versus placebo or control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Ability to void spontaneously after TWOC without the need for re‐catheterisation Show forest plot

9

1094

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [1.36, 1.76]

1.1 Alfuzosin versus control

5

667

Risk Ratio (M‐H, Fixed, 95% CI)

1.40 [1.19, 1.64]

1.2 Tamsulosin versus control

3

321

Risk Ratio (M‐H, Fixed, 95% CI)

1.97 [1.49, 2.59]

1.3 Doxazosin versus control

1

46

Risk Ratio (M‐H, Fixed, 95% CI)

1.09 [0.66, 1.81]

1.4 Silodosin versus control

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

2.09 [1.26, 3.48]

2 Incidence of recurrent urinary retention Show forest plot

8

1023

Risk Ratio (M‐H, Fixed, 95% CI)

0.69 [0.60, 0.79]

2.1 Alfuzosin versus control

5

667

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.60, 0.85]

2.2 Tamsulosin versus control

2

249

Risk Ratio (M‐H, Fixed, 95% CI)

0.66 [0.50, 0.87]

2.3 Doxazosin versus control

1

47

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.65, 1.48]

2.4 Silodosin versus control

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.37 [0.18, 0.74]

3 Number with adverse effects due to alpha‐blocker treatment Show forest plot

5

1064

Risk Ratio (M‐H, Fixed, 95% CI)

1.19 [0.75, 1.89]

3.1 Alfuzosin versus control

3

868

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.53, 1.54]

3.2 Tamsulosin versus control

1

149

Risk Ratio (M‐H, Fixed, 95% CI)

2.71 [0.90, 8.14]

3.3 Doxazosin versus control

1

47

Risk Ratio (M‐H, Fixed, 95% CI)

3.13 [0.13, 73.01]

4 Number with serious adverse effects due to alpha‐blocker treatment Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 Alfuzosin versus control

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Number of drop‐outs due to adverse effects of alpha blockers treatment Show forest plot

5

705

Risk Ratio (M‐H, Fixed, 95% CI)

3.94 [1.28, 12.12]

5.1 Alfuzosin versus control

3

509

Risk Ratio (M‐H, Fixed, 95% CI)

2.83 [0.62, 12.93]

5.2 Tamsulosin versus control

1

149

Risk Ratio (M‐H, Fixed, 95% CI)

6.91 [0.87, 54.76]

5.3 Doxazosin versus control

1

47

Risk Ratio (M‐H, Fixed, 95% CI)

3.13 [0.13, 73.01]

Figuras y tablas -
Comparison 1. Alpha blocker versus placebo or control