Methods

Study design: RCT

Period: October 1992‐January 1994

Participants

N: 47 randomised and analysed.

Age: 24‐82 years

Sex: women

Inclusion criteria: genuine stress urinary incontinence (GSUI) or detrusor instability (DI)

Exclusion criteria: not reported

Interventions

For detrusor overactivity incontinence women only (DO)

A (n = x): probanthine

B (n = x): ES

2nd RCT in people with GSUI

C (n = x): PFMT

D (n = x): ES

Outcomes

Cure ‐ defined as cessation of incontinence. A: not reported B: not reported

Improvement defined as reduction in frequency of voids per 24 hours by ≥ 50%, or ≤ 10 voids per 24 hours, or decrease number of pads per 24 hours by ≥ 50%.

Cured or improved: A (n = x): unclear (50% ‘responded well’), B (n = x) 69%, C (n = x) 44%, D (n = x) 66%

Notes

No useable data

Study authors contacted for further data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Methods

Study design: RCT

Setting: Egypt

Follow‐up: 6 weeks’ treatment, 6 months’ follow‐up

Participants

N: 315 randomised, 300 analysed

Mean (SD) age: A, 49.7 (6.0); B, 47.7 (6.0); C, 48.0 (6.0)

Sex: women

Inclusion criteria: ≥ 40 years, no evidence of urinary tract infection, no SUI, no previous history of anti‐incontinence or pelvic surgery or anti‐incontinence drugs (within 3 months), and no history of bladder malignancy.

Exclusion criteria: not reported

Interventions

A: (n = 105) vaginal ES twice weekly for 12 sessions

B: (n = 105) local vaginal oestrogen 0.625 mg/g (Premarin), 2 g daily for 6 weeks

C: (n = ) ES plus local vaginal oestrogen

Outcomes

Voids per day (mean, SD, N)

End of treatment: A 4.7 (0.8), 105. B 5.0 (0.9), 105. C 5 (0.8), 105

3 months: A 5.0 (1.0), 105. B 5.3 (0.9), 105. C 5 (0.8), 105

6 months: A 6.6 (1.5), 105. B 5.0 (0.8), 105. C 5 (0.8), 105

Voids per night (mean SD, N):

End of treatment: A 0.9 (0.7), 105. B 1.4 (0.8), 105. C 0.5 (0.5), 105

3 months: A 1.1 (0.9), 105. B 1.5 (0.8), 105. C 1 (0.9), 105

6 months: A 2.2 (0.9), 105. B 5.0 (0.8), 105. C .5 (0.8), 105

Incontinence episodes (mean SD, N)

End of treatment: A 0.1 (0.3), 105. B 0.4 (0.6), 105. C 0.07 (0.25), 105

3 months: A 0.1 (0.3), 105. B 0.5 (0.6), 105. C 0.09 (0.28), 105

6 months: A 0.4 (0.6), 105. B 0.4 (0.6), 105. C 0.09 (0.28), 105

Urgency episodes (mean SD, N)

End of treatment: A 2 (0.7), 105. B 4 (1.3), 105. C 1.4 (0.7), 105

3 months: A 2.7 (1.0), 105. B 4.5 (1.5), 105. C 1.6 (0.9), 105

6 months: A 4.7 (1.3), 105. B 4 (1.3), 105. C 2 (0.8), 105

QoL score (higher score = greater severity, instrument not reported) (mean SD, N)

End of treatment: A 2.8 (2), 105. B 5 (1.8), 105. C 2.9 (2.2), 105

3 months: A 4 (1.7), 105. B 6 (2), 105. C 3.7 (2.5), 105

6 months: A 7.6 (3), 105. B 6 (2), 105. C 4.8 (1.9), 105

Functional bladder capacity (ml) (mean SD, N)

End of treatment: A 343.8 (46), 105. B 310 (40.6), 105. C 361 (40), 105

Detrusor overactivity (mean SD, N)

End of treatment: A 27/105. B 32/105. C 12/105

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"computer‐generated random numeric table"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not possible to blind participants, other blinding not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No differential withdrawal, no explanation for withdrawals, no indication on how missing data were dealt with in analysis

Methods

Study design: RCT

Setting: Brazil

Follow‐up: 4 weeks' treatment

Participants

N: 28 randomised

Sex: women

Inclusion criteria: female, ≥ 60 years with likely urinary dysfunction, identified by a score ≥ 8 points on OAB‐V8 questionnaire

Exclusion criteria: urinary infection, identified by urine test, history of treatment for OAB and hormone replacement therapy in the last six months, prior surgery to treat UI, neurological diseases base, genital‐urinary cancer history, complaints of pain in the lower abdomen for more than six months, prior pelvic irradiation, genital prolapse above third degree of Baden and Walker scale, use of cardiac pacemakers, metal implants in foot and right ankle region, inability to respond to questionnaires properly and abstentions to treatment

Interventions

A: (n = 15) tibial nerve stimulation (TNS). 8 sessions (2 x 30‐minute sessions per week)F = 10 Hz, T = 200 μs. Sensory threshold, activating superficial cutaneous nerve fibres with larger diameter

B: (n = 13) TNS 8 sessions (2 x 30‐minute sessions per week). F = 10 Hz, T = 200 μs. Motor threshold, non‐painful contraction was induced and "the stimulation can simply make pain relief in the same way that sensory stimulation level (blocking activation of the peripheral or central inhibition."

Outcomes

All scores are higher score = greater severity

ICIQ‐OAB score (mean SD, N)

A 4.46 (2.66), 15. B 4.53 (3.07), 13

Bother of daytime frequency (mean SD, N)

A 3.20 (2.59), 15. B 3.38 (3.17), 13

Bother of nocturia (mean SD, N)

A 3.40 (3.26), 15. B 1.84 (2.51), 13

Bother of urgency (mean SD, N)

A 4.00 (2.59), 15. B 3.53 (3.59), 13

Bother of urgency incontinence (mean SD, N)

A 2.73 (3.65), 15. B 4.38 (4.29)

Micturitions per 24 h (mean SD N)

A 8.33 (2.52), 15. B 7.89 (2.64), 13

Nocturia episodes (mean SD, N)

A 1.26 (1.21), 15. B 1.05 (1.01), 13

Urgency episodes (mean SD, N)

A 0.79 (0.96), 15. B 0.58 (0.65), 13

Urgency incontinence episodes

A 0.33 (0.57), 15. B 0.84 (1.39), 13

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomisation of two groups"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

"blind assessment and comparison between groups"

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"blind assessment and comparison between groups"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No withdrawals reported

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Botucatu Medical School, Unesp ‐ Univ Estadual Paulista, Brazil

Period: January 2001‐February 2002.

Sample size: "Based on outcome measurements with no numerical variable…the statistical test sample size had previously been established as at least 40 women."

Follow‐up: 7‐week treatment period, follow‐up appointments one month after end of treatment

Participants

N: 40 randomised

Mean age:

A: 49.0 (range 41‐79)

B: 47.0 (range 40‐78)

Sex: women

Inclusion criteria: symptoms of predominant urge incontinence

Exclusion criteria: vaginal prolapse greater than grade II (Baden), retention complaint or obstruction diagnosis during USD, urinary infection, changes in cutaneous sensitivity, metal implants, and neurological complaints

Interventions

A: (n = 20): electrostimulation. 3 x 20‐min sessions per week on alternate days over a 7‐week period, performed using Dualpex Uro996. Frequency at 4 Hz, a 2‐to 4‐s work rest cycle and a 0.1 us pulse width. The bipolar square wave could be delivered over a range of 0‐100 mA. Intensity was controlled according to participant discomfort level feedback

B: (n = 20): sham. Same type of vaginal probe with wires disconnected so no electrical energy was supplied

Outcomes

Number of micturitions per 24 h (mean, SD*, N): A: 7.0 (1.78), 20; B: 7.5 (1.78), 20 P = 0.38

1 hour PAD test (g): A: 1.05; B: 1.13

Number of participants with UUI: A: 3/20 (15%), B: 6/20 (31.5%)

Number of participants ‘satisfied’: A: 16/20 (80%), B: 13/20 (65%)

Reduction in "analog wetness sensation": A: 31.5%. B: 26.9%

Reduction in "analog discomfort sensation": A: 39.7%; B: 24.5%

Pelvic floor muscle strength measured with portable perineometer (Dynamed) (cmH₂O) (mean, SD, N): A: 53.8 (18.6), 20; B: 46.8 (12.5), 20

Vaginal cone weight test (g) (mean, SD, N): A: 4.0 (1.3), 20; B: 2.0 (1.1), 20

Notes

No SDs reported (except for 2 outcomes).

*SD calculated by FS using means and P value

No evidence of source of data in review

Information received from study authors

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"In the Randomization the participants in each groups were raffled" (from correspondence with author)

Allocation concealment (selection bias)

Unclear risk

"the allocations were concealed because a nurse, at each session, was responsible for carrying out the random assignment of patients" (from correspondence with author)

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded. ES sessions carried out by physiotherapist and outcome assessment carried out by different personnel (from correspondence with author)

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

ES sessions carried out by physiotherapist and outcome assessment carried out by different personnel (from correspondence with author)

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No withdrawals reported, % given without denominators, unclear if all participants present for follow‐up

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Department of Uroginecology, Federal University of São Paulo, Brazil

Period: August 2001‐September 2005

Sample size: justified (a power calculation was performed based upon a predicted minimum difference of eight episodes of urinary leakage, with a significance level of 0.05, yielding a power estimate of 90% for a sample size of 20 women per each group)

Follow‐up: 12 weeks' treatment, 1‐year follow‐up

Participants

N: 77 randomised, 64 analysed

Mean age (SD): A 51.9 (13,4); B 51.5 (11.4); C 54.1 (11.6)

Sex: women

Inclusion criteria: OAB and DO

Exclusion criteria: persistent urinary tract infection, inability to comply with regular follow‐up visits, current pregnancy, postvoid residual volume greater than 100 mL, contraindications to anticholinergic therapy, cardiac pacemaker, type III stress urinary incontinence, uncontrolled metabolic conditions or indwelling catheterisation, using medications including anticholinergic drugs, calcium antagonists, β agonists, dopamine agonists, striated muscle relaxants, or oestrogens

Interventions

A: (n = 26): oxybutynin immediate release 5 mg twice daily for 12 weeks

B: (n = 25): ES. Ambulatory stimulation applied vaginally by a physiotherapist, twice a week, for 20 min at each session using 1 ms of intermittent biphasic waves, frequency 10 Hz. Current intensity ranged from 10‐100 mA, according to participant tolerance to the procedure.

C: (n = 26): exercises (PFMT), performed twice a week in orthostatic, sitting, and supine positions. Each session had a total duration of 45 minutes. A total of 40 fast (2 and 5 s) and 20 sustained (10 s) contractions with an equal period of relaxation between them were administered by a physiotherapist in the outpatient setting.

Outcomes

Participants with urgency symptoms (subjective)

A 8/22. B 10/21. C 9/21

Participants not satisfied (subjective)

12 weeks: A 5/22. B 10/21. C 5/21

1 year: A 12/22. B 17/21. C 12/21

Participants not cured (objective evaluation: urodynamics)

A 14/22. B 9/21. C 10/21.

Number of leakage episodes per 24 hours (mean, SD, N)

A 7 (10.6), 22. B 7.9 (13.7), 21. C 7.8 (15.3), 21

Number of micturitions per 24 hours (mean, SD, N)

A 6.4 (1.6), 22. B 7.9 (2.63), 21. C 7.1 (2.1), 21

Number of nocturia episodes per night (mean, SD, N)

A 0.9 (0.8), 22. B 1.2 (1.3), 21. C 1.0 (1.1), 21

Number of pads used per 24 hours (mean, SD, N)

A 0.9 (1.5), 22. B 0.9 (1.7), 21. C 0.8 (1.3), 21

Post micturition residual volume, mL (mean, SD, N)

A 4.8 (9.4), 22. B 1.1 (2.5), 21. C 2.1 (3.5), 21

Maximum cystometric capacity, mL (mean, SD, N)

A 517.3 (191.7), 22. B 436.7 (178.7), 21. C 489.0 (141.3), 21

Volume at FDV (mean, SD, N)

A 157.3 (63.8), 22. B 123.8 (59.0), 21. C 137.6 (76.7), 21

*Involuntary detrusor contraction volume, mL (mean, SD, N)

A 188.6 (183.2), 22. B 173.3 (112.4), 21. C 114.3 (154.2), 21

Involuntary detrusor contraction maximal pressure, mmH₂O (mean, SD, N)

A 19.6 (20.9), 22. B 22.4 (6.6), 21. C 17.2 (25.5), 21

Adverse effects

Dry mouth: A 16/22. B, C not reported

Difficulty on micturition: A 2/22. B, C not reported

Dizziness: A 1/22. B, C not reported

Blurred vision: A 1/22. B, C not reported

Constipation: A 1/22. B, C not reported

Notes

*Value for group B reported in paper as 73.3; queried with author and correct value is 173.3.

We contacted the main study author to clarify methodological aspects of the study and request further information.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"blindly randomized to one of the three treatment groups"

Additional information from study author correspondence: "Patients were randomised using a table of random numbers generated by a statistical program on a computer"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Additional information from author correspondence: "patients and researchers knew to which group the patients belonged"

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Additional information from author correspondence: "Data were analysed by a statistician who did not know which group the patients belonged to."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential withdrawal. Adequate explanation for withdrawals

Methods

Study design: RCT

Setting: Department of Gynecology and Obstetrics Hospital das Clínicas de Porto Alegre, Rio Grande do Sul, Brazil

Period: March 2000‐August 2001

Sample size: 36 participants for a power of 80% and a 2:1 ratio

Follow‐up: 6 months

Participants

N: 36

Sex: women

Mean (SD) age: A: 54 (9.5); B: 56 (12.2)

Inclusion criteria: SUI, UUI or MUI, understanding and signing a letter of informed consent

Exclusion criteria: prolapse or first degree urogenital prolapse, intrinsic sphincter deficiency, cardiac pacemaker, pregnancy or in the puerperal period, post‐menopausal climacteric's symptoms and signs of urogenital atrophy, genitourinary surgery during the previous 6 months, previous ES of the pelvic floor, medication chronically known to possibly change voiding function, change in the dose or if they had begun to use a new medication in the last 3 months, or during treatment with ES, reflex urinary incontinence, paradoxical urinary incontinence, urinary incontinence of intravesical obstructive factor, urinary incontinence caused by overflow, characterised by the presence of a large urinary residual volume, urgency incontinence treated with medication during last 3 months, or during treatment with ES; reflex urinary incontinence (clear presence of neurological lesions); paradoxical urinary incontinence (presence of intravesical obstructive factor); urinary incontinence caused by the presence of a large urinary residual volume; people with urge incontinence who had treatment with medication during last 3 months.

Interventions

A: transvaginal ES (n = 24). Battery‐powered, portable device, 20 or 50 Hz, a pulse width of 300 ms, with asymmetrical biphasic pulses, an adjustable current intensity (0–100 mA), a 1 s rise time, sustained for 5 s and resting for 5 s. A time‐of‐use counter allowed a check on patient compliance with treatment, because it stored in the microcontroller memory the total time of use, corresponding to the time during which current actually circulated through the electrodes. Two 20‐min sessions per day while recumbent, for 12 weeks.

UUI or MUI: equipment programmed for 20 Hz

Stress urinary incontinence: equipment programmed for 50 Hz.

UUI or MUI: equipment programmed for 20 Hz

SUI: equipment programmed for 50 Hz

B: sham (n = 12). Identical equipment and regimen but without electrical stimulus

All participants requested to complete 3‐day voiding diary at beginning of study and again at 12 weeks’ follow‐up.

Outcomes

Number of participants cured/improved at 12 weeks

A: 21 (88%) B: not reported

Number of voids per 24 hours (mean (SD) N)

A: 7.5 (2.0) 24; B: 10.5 (2.8) 12

Number of nocturia episodes (mean, SD, N)

A: 1.1 (0.5), 24; B: 2.3 (0.9), 12.

Number of incontinence episodes per 24 h (mean, SD): A: 1.3 (1.0) 24; B: 3.0 (0.9) 12

Number of uninhibited contractions per 24 h (mean, SD): A: 2 (8), 24; B: 4 (not reported)

Maximum bladder capacity (mean, SD, N)

A: 425.0 mL (97.8), 24; B: 316.7 mL (71.8), 12

Notes

Compliance: 60 h of equipment use was expected.

A: 46 hours

B: 40 hours

We contacted the main author of the study to clarify methodological aspects of the study and request further information. Awaiting reply

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The participants were randomized before the study by drawing lots"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

"The participants were randomized before the study by drawing lots, with no participation by the examiner who, at the start of the treatment of each patient, was already receiving the group determined by randomization (study or control). Likewise the patients did not know into which group they had been placed (active or placebo). The patients in the control group were evaluated at different times from the study group, to avoid any exchange of information among them"

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Urodynamic evaluations carried out by examiner unaware of the study. Participants also unaware of intervention allocated

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No withdrawals reported

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Female Urology Clinic of the Hospital das Clínicas at Campinas (HC/UNICAMP), Brazil

Follow‐up: 4 weeks

Participants

N: 37 randomised and analysed

Mean age: 47.73 (10.90)

Sex: women

Inclusion criteria: 18‐85 years, symptoms of OAB for > 6 months, voiding frequency > 8 micturitions daily, episodes of nocturia and/or urgency

Exclusion criteria: pregnancy, neurological problems, accentuated dystopias (stages II and III in the definitions of ICS), urinary tract infection and urinary stress incontinence

Interventions

A: (n = 21): ES. Transcutaneous posterior tibial nerve stimulation. 8 sessions with Dualpex device 961, 30 min twice a week

B (n = 16) sham. Electrodes placed without electricity

Outcomes

Participants with urgency

A 9/21. B 10/16.

Frequency of micturitions (mean, N)*

A 8.29, 21 B 10.55, 16

Decrease in frequency and urgency

A 62.5%. B 42.8% (P < 0.05)

OAB‐Q severity score

A 31.72 (18.25), 21. B 51.21 (32.11), 16

OAB‐Q total score

A 83.99 (16.99), 21. B 66.63 (25.06), 16

Nocturia episodes

A 1.14 (1), 21. B 2.06 (1.2), 16

Notes

*Contacted study author to ask for SDs, no reply. Estimated SD used in meta‐analysis

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The randomization process was made by the FCM's statistics department"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

"The evaluations were carried out by the investigator or the physiotherapist, and treatment was performed by the same person who evaluated the patient, thus creating a bond with the physiotherapist."

Blinding of outcome assessment (detection bias)
All outcomes

High risk

"The evaluations were carried out by the investigator or the physiotherapist, and treatment was performed by the same person who evaluated the patient, thus creating a bond with the physiotherapist."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All randomised participants included in analysis. "All women were submitted to eight sessions of therapy, all the questionnaires were completed and none of the women failed to attend the sessions more than 3 times. The reasons for missing sessions were very variable, but did not alter the results of the study."

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: hospital and private clinic (University Hospital Maastricht, Department of Urology, the Netherlands)

Sample size: a level of significance of 95%, a power of 80%, an expected dropout rate of 10%, and an expected improvement of bladder overactivity status of treatment groups in comparison with non‐treatment group, expressed as a decrease of approximately 30% in the Detrusor Activity Index (DAI), 20 participants in each of the 4 groups had to be recruited. Therefore, the intended sample size was set on 80 people.

Follow‐up: unclear (9 weeks?)

Participants

N: 80 randomised, 68 participated and analysed

(12 excluded as randomised ‘erroneously’)

Mean (SD) age:

A: 50.5 (11.8)

B: 55.6 (14.8)

C: 61.9 (13.5)

D: 52.3 (15.4)

Sex: women

Inclusion criteria: Detrusor Activity Index 0.5 or greater; > 18 years, female, drug‐free interval of at least 4 weeks before start of the study for the following drugs: anticholinergic, beta sympathicomimetic, alpha‐blocker and psychopharmacological agents.

Exclusion criteria: mechanical intravesical obstruction, urinary calculus, repetitive symptomatic UTI (> 3 x per year), colpitis, clinical evidence of disordered action of heart (Lown III), pacemaker, pregnancy of lactating period, inability to comply with follow‐up, treatment with physical therapies within 3 months before start of therapy, neurogenic or congenital disorders resulting in urinary incontinence (e.g. spina bifida), psychological disorders, irritation of the vagina (consult with the general practitioner and participant), poor adjustable diabetes mellitus: last HbA1C > 10, contra‐indication for the use of an intravaginal or anal electrode, not able to understand Dutch, not able to travel

Interventions

A: controls (n = 14)

B: Lower Urinary Tract Exercises (LUTE) (n = 18). 1 session per week for 9 weeks. Patient information and education; bladder training; specific PFMT aiming at detrusor inhibition reflex (DIR); toilet behaviour aiming at the aspects of the micturition process itself

C: FES (n = 17). FES was applied vaginally through plug‐mounted electrodes. The maximum level of the ES was 100 mA (Ieff = 6 mA), participant was instructed to use. The maximal characteristics were (frequency modulation of 0.1 s trains of rectangular biphasic 200 µs long pulses which varied stochastically between 4 and 10 Hz). Duration of treatment unclear

D: FES + LUTE group (n = 19). Same LUTE programme plus an additional weekly FES session (for 9 weeks)

Dropouts: A ?0, B 5, C 3, D 2

Outcomes

Detrusor Activity Index (DAI): urodynamic variables of ambulatory cystometry combined with data from micturition diary (i.e. condition‐specific measure; 0‐1 scale where higher = worse) (mean, SD):

A 0.80 (0.26) 14, B 0.62 (0.33) 18, C 0.57 (0.33) 17, D 0.84 (0.27) 19

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomization was done in blocks of four using opaque and sealed envelopes"

Allocation concealment (selection bias)

Low risk

"Randomization was done in blocks of four using opaque and sealed envelopes"

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Besides the participant and the physical therapist all others, involved in randomisation, registration and evaluation were blinded for group allocation.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Besides the participant and the physical therapist all others, involved in randomisation, registration and evaluation were blinded for group allocation.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential dropout

A total number of 10 women dropped out of the trial. 1 woman stopped before start of therapy, because she considered the burden of investigation too high. During the treatment period, 5 women stopped because of illness (2 in group II and 2 in group III or allegedly reasons of too much burden felt (1 in group IV).

"Missing data in the set of post‐treatment DAI‐scores were substituted by post‐treatment means of the empirical data according to the intention‐to‐treat principle."

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: Brazil

Period: August 2008‐2010

Sample size: not reported

Follow‐up: 4 weeks

Participants

N: 73 randomised, unclear how many included in analysis

Mean (SD) age: 61.3 (not reported)

Sex: women

Inclusion criteria: women with OAB

Exclusion criteria: not reported

Interventions

A: (n = 22) PFMT. 12 sessions. Group exercises performed in sitting, standing and supine positions with 20 contractions of 2 s, 10 contractions of 5 s and 5 contractions every 10 s.

B: (n = 22) ES, pulse width 200 ms. Transcutaneous posterior tibial nerve stimulation (TPTNS). Frequency 10 Hz. 12 x 30‐min sessions

C: (n = 16) functional ES with vaginal electrode, pulse width 500 microseconds. Frequency 10 Hz.12 30‐minute sessions.

D: (n = 13) oxybutynin. 5 mg immediate release twice daily for 12 weeks

Outcomes

Satisfaction

A 91% (20/22). B 77% (17/22). C 69% (11/16). D 61.5% (8/13)

(not satisfied: A 2/22. B 5/22. C 5/16. D 5/13.)

Notes

Data presented for urinary frequency, nocturia, urgency and urgency incontinence but not usable

Unable to find contact details for study authors

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomized into four treatment groups"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No withdrawals reported. Outcome data presented without denominators or SDs

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: UK

Period: not reported

Sample size: not reported

Follow‐up: 6 weeks

Participants

N: 30 randomised, 28 analysed

Sex: men and women

Mean age: 84.2 (10.0)

Inclusion criteria: men and women > 65 in residential care home settings or sheltered accommodation with bothersome LUTS, urinary incontinence, faecal incontinence, or constipation; capacity to provide ongoing informed consent to participate.

Exclusion criteria: pacemaker in situ, leg ulcers or broken skin on lower limb, peripheral vascular disease, reduced/absent sensation at the electrode sites, moderate or severe cognitive impairment or learning difficulties, UTI on assessment, or clinical diagnosis of only SUI

Interventions

A: (n = 15) PTNS. 2 x 30‐min sessions per week for 6 weeks. Frequency 10 Hz and pulse width 200 ms in continuous modeThe intensity level of the stimulation current range (0‐50 mA).

B: (n = 13) Sham. Same procedure with stimulation current reduced to 2 mA

Outcomes

Number of participants with no improvement in incomplete bladder emptying

A 7/15, B 12/13

Number of participants with no improvement in voiding frequency

A 4/15, B 7/13

Number of participants with no improvement in urgency

A 4/15, B 9/13

Number of participants with no improvement in nocturia

A 8/15, B 10/13

Number of participants with no improvement in weak urinary stream

A 6/15, B 12/13

Number of participants with no improvement in intermittency

A 10/15, B 11/13

Number of participants with no improvement in urinary straining

A 9/15, B 12/13

Number of participants with no improvement in frequency of UI episodes

A 8/15. B 11/13.

Number of participants with no improvement in amount of urine leaked

A 7/15. B 11/13.

Number of participants with no improvement in interference with everyday life

A 6/15. B 7/13.

Number of participants with no improvement in constipation

A 14/15, B 6/13

Number of participants with no improvement in bowel urgency

A 11/15, B 12/13

Number of participants with no improvement in faecal leakage

A 8/15, B 10/13

Reduction in AUASI score (median, IQR, N):

A ‐7 (‐8 to ‐3), 15. B 1 (‐1 to 4), 13. (P < 0.001, Mann‐Whitney U 16.5000, Z ‐3.742)

Reduction in ICIQ‐SF score (median, IQR, N):

A 2 (0 to ‐6), 15. B 0 (‐3 to 3), 13. (P = 0.132)

Number of participants with no improvement in ICIQ‐SF score

A 5/15. B 7/13

Notes

Two participants had predominantly faecal incontinence.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"online randomization service"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants blinded. "Staff were blind to the group allocation."

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

"Fidelity to the protocol was high and 28 of the 30 participants completed the 12 session course, with two discontinued at session five because they developed infections"

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Australia

Period: January 1996–February 1997

Sample size: 40% volume increase and 35% decrease in maximum detrusor pressure 16 participants would be required per group for an 80% chance of detecting significant change

Follow‐up: immediately following single ES session

Participants

DO group: 48 randomised

Urgency group: 31 randomised

Mean (SD) age: overall 55.4 (16.8). DO group: 56.5 (16.8). Urgency group: 56.3 (16.9)

Sex: women

Inclusion criteria: DO or urgency

Exclusion criteria: UTI, pregnancy, cardiac pacemaker, impaired cognition, neurogenic bladder dysfunction or cystocele beyond the introitus

Interventions

DO group

A1 (n = 16) TENS – suprapubic placementFrequency 150 Hz, 200 ms pulse width

B1 (n = 16) TENS – sacral placementFrequency 10 Hz, 200 ms pulse width

C1 (n = 15) sham ES

Urgency group

A2 (n = ?) TENS – suprapubic placementFrequency 150 Hz, 200 microsecond pulse width

B2 (n = ?) TENS – sacral placement Frequency 10 Hz, 200 mspulse width

C3 (n = ?) sham ES

Outcomes

Vol. at FDV (mean, SD, N)

A1 208.5 (132), 16. B1 154 (61), 16. C1 186 (77), 15

A2 180 (51). B2 111 (37). C2 138 (51) (n not reported)

Max. cystometric capacity (mean, SD, N)

A1 352 (144), 16. B1 305 (146), 16. C 313.5 (81), 15

A2 291 (51). B2 241 (53). C2 285 (45) (n not reported)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomized to 3 groups"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

"Both the supervising urogynaecologist and the patient were blind to group allocation"

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Data for urgency group not presented with numbers of participants, unclear how many in urgency group were randomised to each intervention

Methods

Study design: RCT

Multicentre or single‐centre: 4 centres

Setting: Rush‐Presbyterian‐St.Luke's Medical Center, Chicago; Methodist Hospital, Indianopolis; Greater Baltimore Medical Center; and the Oregon Health Science University, Portland, USA

Period: not reported

Sample size: not reported

Follow‐up: 8 weeks

Participants

N: 148 enrolled, 121 randomised and analysed

Mean (SD) age for all participants (not stratified by GSUI/DO): A 56 (11.9); B 57.7 (12.4)

Sex: women

Inclusion criteria: women with symptoms or urodynamic evidence of genuine stress incontinence or detrusor instability

Exclusion criteria: urinary incontinence other than genuine stress incontinence, detrusor instability, or mixed incontinence. Age < 25 years, leakage episodes ≤ 3/weeks, inadequate cognitive ability (investigator judgment), infected urine, anatomic defect that precluded use of device, postvoid residual > 100 mL, implanted electric device, genitourinary surgery < 6 months previously, medication alteration ≤ 3 months previously, anticipated geographic relocation during study

Interventions

For DO and mixed women only (n = 61):

A (n = 33) transvaginal electric stimulation. Device: InCare Microgyn II. 20 Hz frequency, 2‐second/4‐second work‐rest cycle, pulse width 0.1‐us. Bipolar square wave could be delivered over a range of 0‐100 mA. 20 min daily

B (n = 28) sham. Identical device with disconnected wire so no electricity supplied. 20 min daily

Outcomes

Definition of cure: absence of abnormality as measured objectively by urodynamics

Number of participants with DO:

A 14/32, B 23/28

UI frequency 2.2

No improvement 2.3

Compliance 2.4

Notes

We contacted the main author of the study to request further information about further 3 publications of the same study. The study authors replied with information.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random numbers, and used for stratified randomisation

Allocation concealment (selection bias)

Unclear risk

The study nurse at each site was responsible for carrying out the random assignment of participants in accordance with the randomisation scheme.

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

The study nurse at each site was aware of the difference in probes, however the physician investigators were masked as to the type of vaginal probe provided to each participant.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Data sent to centralised data manager

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

"A total of 148 women were enrolled, 18% of whom withdrew from the study, leaving of a total 121 participants who completed the study. There was no statistically significant difference between the treatment groups with respect to withdrawal rates: 21% for the sham group and 14% for the stimulation group."

No explanation reported for withdrawals

Methods

Study design: RCT

Setting: China

Follow‐up: 4 weeks’ treatment

Participants

N: 100 randomised

Inclusion criteria: neurogenic DO secondary to spinal cord injury

Exclusion criteria: urinary tract infection, tumour of the urinary system, urinary calculus, vesicoureteral reflux confirmed by video urodynamics, bladder compliance > 10 mL/cmH₂O

Interventions

A (n = 50) PTNS using adhesive skin surface electrodes. Continuous, bi‐polar square wave form with pulse duration of 200 μs and stimulation frequency of 20 Hz. "The stimulator was controlled to determine the minimal current needed to induce a toe twitch. The intensity was then increased to the highest level tolerated by the participant who cannot induce lower limb muscle spasm in complete SCI patients and uncomfortable feeling on stimulating sites in incomplete SCI patients"

B (n = 50) solifenacin succinate 5 mg per day

Outcomes

Leakage volume per day (ml) (mean SD, N)

A 541.4 (47.5), 50. B 449.1 (89.2), 48

I‐QoL (mean, SD, N)

A 25.2 (1.0), 50. B 24.2 (1.0), 48

Adverse effects: A 0/50 B 5/50 (all dry mouth)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"the patients were randomized into two groups"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not possible to blind participants, other blinding not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential withdrawal, adequate explanation for withdrawals

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Iran

Follow‐up: 12 weeks’ treatment

Participants

N: randomised and analysed

Sex: women

Inclusion criteria: women with neurologic OAB confirmed by urodynamic diagnosis

Exclusion criteria: not reported

Interventions

A: PTNS. 34‐gauge needle placed 5 cm near internal malleolus. Sessions lasted 30 min

B: 4 mg tolterodine daily for 3 months

Outcomes

Sexual function

Subjective assessment of pelvic disorders

Notes

No useable data. Contacted study author 21‐04‐2016

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"computer generated numbers"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

"nor patients nor the physician were blinded to the patient’s group"

Blinding of outcome assessment (detection bias)
All outcomes

High risk

"nor patients nor the physician were blinded to the patient’s group"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Before study began, 2 in PTNS group and 8 in the control group withdrew. No explanation reported

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: Rome, Italy

Period: not reported

Sample size: not reported

Follow up: not reported

Participants

N: 35 randomised and analysed

Mean (SD) age: not reported

Sex: 28 women, 7 men

Inclusion criteria: OAB not responding to antimuscarinic therapy

Exclusion criteria: not reported

Interventions

Says all cases treated in the same way as detailed in Stoller 1999.

A (n = 17, 14 F, 3 M) weekly PTNS

B (n = 18, 14 F, 4 M ) 3 times per week PTNS – every 2 days

Outcomes

Success = > 50% reduction in micturitions/24 hours

OR

If incontinent, > 50% reduction in UI episodes/24 hours

A 11/17 (4/11 incontinent participants). B 12/18 (5/11 incontinent participants)

Subjective improvement after 6‐8 sessions

A 17/17. B 18/18

Adverse effects

A 0/17. B 0/18

Adverse effects: “None of the patients discontinued the treatment and all considered it tolerable and painless”

Incontinence episodes per 24 hours (median, range, N)

A 1 (0‐3), 11. B 1 (0‐3), 11

Micturitions per 24 hours (median, range, N)

A 8 (5‐15), 17. B 8 (6‐18), 18

SF‐36 (median, range, N)

A 62 (24‐81), 17. B 62 (25‐80), 18

I‐QoL (median, range, N)

A 77 (35‐100), 17. B 78 (33‐100), 18

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomly assigned"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not possible to blind participants, other blinding not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All participants randomised seem to be included in analysis

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Tor Vergata University Hospital in Rome, Italy

Period: February 2007‐February 2009

Sample size: with a sample size of 15 in each group this study had a power of 82.3% to yield a statistically significant result assuming that the difference in proportions was 0.45 (specifically 0.05 vs 0.50). This effect was selected because the magnitude was reasonable according to previously published findings. To account for a dropout rate of 10% the number of participants to be recruited was set at 17 for each group, 34 total

Follow‐up: 4 weeks

Participants

N: 35 randomised, 32 analysed

Mean age (no SD reported): A 44.9; B 45.5

Sex: women

Inclusion criteria: female, urgency incontinence and urodynamically diagnosed detrusor overactivity incontinence, unresponsive to behavioural and rehabilitation therapy or antimuscarinics, able to give written, informed consent, 18 years of age or older, mentally competent and able to understand all study requirements, able to understand the procedures, advantages and possible side effects, willing and able to complete a 3‐day voiding diary and I‐QoL questionnaire, bladder capacity 100 mL or greater, no signs of neurologic abnormalities at objective examination; no history of neurologic pathology, no pharmacological treatment or pharmacological treatment unchanged for 30 days before beginning the study.

Exclusion criteria: pregnancy or intention to become pregnant during the study, active UTI or recurrent UTI (more than 4 per year), presence of urinary fistula, bladder or kidney stones, interstitial cystitis, cystoscopic abnormalities that could be malignant, diabetes mellitus, cardiac pacemaker or implanted defibrillator

Interventions

A (n = 18) PTNS. 12 sessions, 30 min, 3 times a week for 4 weeks. 34‐gauge needle inserted percutaneously approx 5 cm cephalad to the medial malleolus of right or left ankle; surface electrode placed on medial aspect of ipsilateral calcaneous. Stimulation current (0‐10 mA) with a fixed frequency of 20 Hz and a pulse width of 200 ms was increased until flexion of the big toe or fanning of all toes became noticeable. The current was set at the highest level that was tolerable to the participant.

B (n = 17) sham. Same schedule as PTNS group with stimulator briefly activated for approximately 30 seconds so the participant felt a minor electrical sensation in the skin.

Outcomes

Number of participants with < 50% reduction in urgency incontinence episodes:

A 5/17. B 18/18

Number of incontinence episodes per 24 hours (mean, range, N):

A 1.8 (1.2‐2.2), 17. B 3.8 (3.0‐4.5), 15

Number of micturitions per 24 hours (mean, range, N):

A 9.5 (8.4‐10.7), 17. B 13.9 (11.3‐16.5), 15

Voided volume mL (mean, range, N):

A 150.5 (126.8‐174.3) 17. B 150.4 (125.8‐175.1), 15

I‐QoL score (mean, range, N):

A 69.9 (65.8‐73.3), 17. B 70.6 (62.2‐79.1), 15

Notes

Contacted study author asking for SDs 27‐11‐14

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Computer‐generated randomization list."

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

To verify participant blindness with respect to the assigned treatment after 3 sessions participants were asked which procedure they believed they received.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

The results of the 2 groups were collected by 2 physicians, and analysed by a third physician and a statistician, both of whom were blinded regarding the procedure used in any single participant.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

In the PTNS group 1 participant and in the placebo group 2 did not complete the study for personal reasons not related to the used technique. There remained 17 participants in the PTNS group and 15 in the placebo group. There was a loss of less than 20% so considered at low risk of bias.

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: USA

Period: not reported

Sample size: "to achieve a power of 0.80 with an estimated conventional large effect size (f = 0.40), we sought a sample size of 66 women (33 with urge UI and 33 with stress UI) with 11 participants per treatment by diagnosis group."

Follow‐up: 8 weeks

Participants

N: 63 randomised, 48 analysed

Mean (SD) age:

UUI overall 61.0 (12.4), A 57.3 (12.5) B 66.5 (12.4) C 63.0 (14.5)

SUI overall 55.1 (14.4), D 52.7 (15.0) E 63.6 (13.3) F 48.2 (16.2)

Sex: women

Inclusion criteria: SUI or UUI diagnosed by urodynamics or Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire, parous or nulliparous women 21 years or older, manual dexterity to dial the Liberty Electrical Stimulation Unit, fluent English, ≥ 3 incontinent episodes in 3 days. Women on HRT to maintain same oestrogen intake throughout study, women not taking hormones were asked not start an oestrogen regimen during study.

Exclusion criteria: zero score on Oxford pelvic floor muscle strength scale, denervation injury to the sphincters, anti‐incontinence surgery, vaginal extent to extent that middle finger could not be inserted into vagina, BMI > 50, stage III/IV prolapse, pregnancy, neurologic conditions, any potentially confounding prescriptions drugs

Interventions

UUI

A (n = 7) intravaginal ES plus PFMT. 14 sessions of 60 min PFMT exercises, then 30 min (12.5 Hz) at highest tolerable intensity Tampon‐shaped Liberty ES device

B (n = 8) PFMT alone. 60 minutes twice a week for 8 weeks

C (n = 7) no active treatment

SUI

D (n = 14) as per group A

E (n = 15) as per group B

F (n = 12) as per group C

Outcomes

York Incontinence Perception Scale (YIPS) score (higher score is better) (mean, SD, N):

UUI: A 41.2 (10.2), 6. B 47.0 (5.5), 6. C 28.8 (2.9), 6

SUI: D 46.4 (7.2), 9. E SUI 44.8 (6.3), 12. F 29.9 (2.2), 9

% change in YIPS score (mean, N):

UUI: A 38.7%, 6. B 78.7%, 6. C ‐2.4%, 6

SUI: D 57.8%, 9. E SUI 37.0%, 12. F 2.0%, 9

Pelvic floor muscle strength, cm H₂O (mean, SD, N):

UUI: A 27.0 (16.0), 6. B 47.2 (22.7), 6. C 34.3 (25.5), 6

SUI: D 36.7 (14.1), 9. E 32.5 (18.5), 12. F 26.1 (18.6), 9

% change in pelvic floor muscle strength, cm H₂O:

UUI: A 8.9%, 6. B 155.1%, 6. C 1.2%, 6

SUI: D 119.8%, 9. E 49.8%, 12. F 5.2%, 9

Incontinence episodes in 3 days (mean, SD, N):

UUI: A 3.0 (4.4), 6. B 2.3 (2.9), 6. C 7.8 (5.9), 6

SUI: D 1.4 (1.6), 9. E 4.1 (4.2), 12. F 8.0 (5.6), 9

*incontinence episodes per day (mean, SD, N):

A 1.0 (1.47), 6. B 0.8 (0.97), 6. C 2.6 (1.97), 6

D 0.5 (0.53), 9. E 1.4 (1.4), 12. F 2.7 (1.87), 9

% change in incontinence episodes in 3 days (mean, N):

UUI: A ‐78.1%, 6. B ‐70.5%, 6. C ‐4.0%, 6

SUI: D SUI ‐83.7%, 9. E SUI ‐66.9%, 12. F SUI 50.9%, 9

Frequency of micturitions in 3 days (mean, SD, N):

UUI: A 25.7 (9.4), 6. B 23.5 (5.9), 6. C 24.2 (10.4), 6

SUI: D 24.1 (10.4), 9. E 22.8 (8.3), 12. F 24.6 (8.9), 9

*frequency of micturitions per day (mean, SD, N):

A 8.6 (3.13), 6. B 7.8 (1.97), 6. C 8.1 (3.47), 6

D 8.0 (3.47), 9. E 7.6 (2.77), 12. F 8.2 (2.97), 9

% change in frequency of micturitions in 3 days (mean, N):

A ‐19.2%, 6. B ‐16.7%, 6. C 27.4%, 6

D ‐6.6%, 9. E ‐8.8%, 12. F ‐14.9%, 9

Notes

Different numbers of participants reported in thesis and journal article.

*Mean (SD) per day calculated from 3‐day data: mean and SD divided by 3

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"2 containers were prepared representing diagnosis groups (urge or stress incontinence). Each container held 33 slips of paper with 11 reading “e‐stim,” 11 reading “therapeutic exercise” and 11 reading “control.” The office assistant offered the correct diagnostic container to the participant on the second visit.”

Allocation concealment (selection bias)

Low risk

"2 containers were prepared representing diagnosis groups (urge or stress incontinence). Each container held 33 slips of paper with 11 reading “e‐stim,” 11 reading “therapeutic exercise” and 11 reading “control.” The office assistant offered the correct diagnostic container to the participant on the second visit.”

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

"The primary researcher performed the outcome measures and administered the exercise programs. She was blinded to the participants’ diagnosis as determined by the MESA but was not blinded to group allocation."

Blinding of outcome assessment (detection bias)
All outcomes

High risk

"The primary researcher performed the outcome measures and administered the exercise programs. She was blinded to the participants’ diagnosis as determined by the MESA but was not blinded to group allocation."

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Some differential attrition: "of those who dropped out after randomization most (11/16) were in the exercise and stimulation group...there was no indication that discomfort was a factor."

Methods

Study design: RCT

Multicentre or single‐centre: 3 centres in Sweden

Period: September 2001 and December 2005

Sample size: the power analysis was calculated on the basis of the primary outcome measure, reduction of micturitions per 24 h. The minimal patient‐perceivable improvement has been found to be a mean reduction of micturitions per 24 h equivalent to 20%. A reduction smaller than 20% would thereby not be of any significant clinical importance. There is a large uncertainty regarding the efficacy that can be expected for both ES treatment and drug treatment being 30% to 50%. Under the assumption that ES treatment would give a 70% reduction of symptoms and drug treatment (tolterodine) a 50% reduction and thereby give a difference between treatments of 20%, a Chi² test with a 2‐sided significance level of 5% yielded a power of 80% for a sample size of 103 participants in each group. If the assumption was even bigger difference in efficacy, 70% for ES treatment vs. 40% for tolterodine, the sample size with an additional 10% to compensate for dropouts would be 55 participants in each group.

Follow‐up: 24 months

Participants

N: 72 randomised and 61 analysed at 6 months, 52 analysed at 12 months, 46 at 24 months

Sex: Women

Mean (SD) age: A 55 (11); B 61 (12)

Inclusion criteria: urgency incontinence symptoms for ≥ 3 months, increased frequency of micturition (≥ 8 micturitions per 24 hours), mean volume of urine voided per micturition ≤ 200 mL, total urine volume per 24 hours of < 3000 mL during a 48‐hour bladder diary

Exclusion criteria: Persistent UTI, post‐void volume greater than 150 mL, history of neurological disease or dementia, pregnancy, contraindications to anticholinergic therapy, and a cardiac pacemaker. Participants were also excluded if they had used tolterodine or any other anticholinergic drugs in order to treat urgency/urge incontinence during the last 2 months or had received ES treatment within the last 3 years.

Interventions

A (n = 33). ES vaginally and/or transanally with the MS‐310 Device, MIC Rehab AB. Over 5‐7 weeks, 10 stimulation treatments 1‐2 times per week for 20 min with a frequency of 5‐10 Hz. The maximum ES was done with maximum tolerable intensity, which was adjusted up to the level of tolerable discomfort.

B (n =31) tolterodine SR 4 mg orally once daily for 6 months, with dose reduction allowed to tolterodine SR 2 mg daily if intolerable side effects occurred

Outcomes

Number of participants with moderate or severe urgency symptoms:

A 10/33, B 12/31

Number of participants with no improvement in urgency symptoms:

A 9/33, B 9/31

Change in frequency of micturition (mean, 95%CI (SD)*, N):

6 months:

A ‐2.8 (‐3.6 to ‐2.2 (1.96)), 30. B −3.2 (−4.1 to −2.4 (2.41)), 31.

12 months:

A −3.1 (95% CI, −4.0 to −2.1 (2.65)), n = 30. B −3.1 (95% CI, −4.3 to −1.9 (3.41)) n = 31

24 months:

A −3.4 (−4.6 to −2.2 (3.35), n = 30. B −3.7 (−4.8 to −2.6 (3.12)), n = 31

Change in mean urine volume (mL) (mean, 95%CI (SD)*, N):

A 54 (28‐80 (72.66)), 30. B 55 (36‐74 (53.97)), 31

Side effects:

A 0/33

B** 9/30 dry mouth, 1/30 muscular pain

KHQ: see Table 3. Various outcomes reported

Notes

*SD calculated by FS, using 95% CI

**based on information received from study author

6‐month data used in analysis because treatment was given for 6 months. Most other included studies provided data for end of treatment period

N per treatment group at 12 and 24 months not given, assumed same as 6 months

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomization sequence was developed centrally, using a computer random number generator."

Allocation concealment (selection bias)

Low risk

"Assignment was enclosed in sequentially numbered opaque sealed envelopes by a person not involved in the study. Patients were included into the study and allocated to treatment group by the clinical staff responsible for the study at each participating center, by opening the lowest numbered envelope"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

"Blinding of study personnel and participants to treatment assignment for the duration of the study was not possible due to the nature of the interventions."

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential dropout. Adequate explanation for withdrawals

Methods

Study design: RCT

Multicentre or single‐centre: unclear

Setting: Belgium

Period: November 2010 – November 2012

Sample size: 15 per group required for 80% power to detect between‐group difference

Follow‐up: 9 weeks’ treatment, 6 months’ follow‐up

Participants

N: 31 randomised and analysed

Mean (SD) age: A 43.5 (14.0). B 40.5 (9.5)

Sex: women and men

Inclusion criteria: EDSS score < 7 and, urgency symptoms, nocturia, urgency incontinence, urinary retention and/or weak stream, post‐voiding symptoms such as incomplete bladder emptying sensation

Exclusion criteria: acute MS episodes during the study, UTI, pelvic‐perineal treatment in the past 6 months, pregnancy

Interventions

A (n = 16) PFME with biofeedback. One 30‐min session per week for 8 weeks

B (n = 15) ES + PFME. As per group A plus transcutaneous posterior tibial nerve stimulation. Frequency 10 Hz, 220 µs pulse width. One 30‐min session per week for 9 weeks. Rectangular biphasic pulse. An external electrode was located 5 cm above the medial malleolus and 1 cm behind the tibia. The other electrode was positioned on the dorsum of the foot. 20 s on, 4 s off

Outcomes

Number of participants not satisfied:

A 1/16. B 4/15

SF‐Qualiveen total score (higher score = greater severity) (median, IQR, N):

9 weeks: A 1.000 (0.656, 1.719), 16. B 1.375 (0.625, 2.188), 15

6 months: A 1.313 (0.687, 1.625), 16. B 1.500 (0.344, 2.094), 15

*mean, SD, N

9 weeks: A 1.07 (0.65), 16. B 1.51 (0.83), 15.

6 months: A 1.21 (0.74), 16. B 1.39 (0.91), 15

Bladder hyperactivity score (median, IQR, N):

9 weeks: 5.00 (1.50, 8.00), 16. B 6.00 (2.5, 9.25), 15

6 months: 7.00 (3.50, 9.50), 16. B 5.00 (4.25, 7.75), 15

*mean, SD, N

9 weeks: A 5.4 (3.67), 16. B 6.75 (3.91), 15

6 months: A 6.42 (3.9), 16. B 6.5 (3.45), 15

Daily urgency episodes (median, IQR, N):

9 weeks: A 1.2 (0.3, 5.0), 16. B 0.7 (0.2, 4.3), 15

6 months: A 2.0 (0.3, 2.7), 15. B 1.4 (0.0, 2.0), 15

*mean, SD, N

9 weeks: A 2.69 (3.02), 16. B 2.63 (3.08), 15

6 months: A 2.25 (2.53), 16. B 1.67 (1.64), 15

Adverse effects: A 0/16. B 0/15

Notes

Subcategories of Qualiveen scores available in paper

Emailed study authors asking for means (SDs) 2 April 2015. Replied with data marked *

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Participants were randomised"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding of participants not possible. Other blinding not reported

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Data analysis was blinded"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential withdrawal. Adequate explanations for withdrawal not reported. Intention‐to‐treat analysis carried out

Methods

Study design: randomised cross‐over trial

Setting: Chile

Follow‐up: switch modalities at 3 months, follow‐up at 6 months

Participants

N: 82 randomised

Sex: not reported

Inclusion criteria: OAB symptoms

Exclusion criteria: unable to comply with follow‐up or had a history of neurological disease

Interventions

A (n = 40 randomised and 31 analysed): transcutaneous posterior tibial nerve stimulation and behavioural therapy. Twice a week for 6 weeks

B (n = 42 randomised and 37 analysed): behavioural therapy. One‐to‐one interview and assessment with a continence physiotherapist and written information

After 3 months both groups switched treatment modalities for another 3 months

Outcomes

After 3 months’ treatment:

Visual analogue scale (VAS) (higher score = greater severity) (mean SD, N):

A 5.81 (2.89), 31. B 7.50 (2.50), 37

Incontinence severity index (ISI) (higher score = greater severity) (mean, SD, N):

A 5.15 (3.23), 31. B 7.38 (4.00), 37.

Patient’s Global improvement (PGI‐I):

A 85.7%. B 60.9%

OAB‐Q (higher score = greater severity) (mean SD, N):

A 100.81 (41.50), 31. B 127.71 (40.64), 37

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"computer generated sequence"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not possible to blind participants

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

High risk

Withdrawals: A 9/40, B 5/42. No explanations for withdrawal

Methods

Study design: RCT

Multicentre or single‐centre: multicentre

Setting: USA

Period: June 2011–December 2013

Sample size: the sample size calculation was determined using the 2‐sided Chi²test with a significance level of 5% and 80% power based upon the following assumptions: (1) proportion of responders at end of 12 weeks of treatment would be 50% in the active (test) group and 25% in the inactive (control) group; (2) a responder was defined as a subject who experienced decrease of ≥ 50% in mean UUI episodes (leaks) between baseline and week 12 of the study; (3) 20% dropout rate

Follow‐up: 12 weeks

Participants

N: 163 randomised

Mean age (SD): A 60.8 (14.3); B 62.4 (13.8)

Sex: 138 women, 25 men

Inclusion criteria: men and women, at least 18 years of age. Failure on primary OAB treatment, such as behaviour modification or fluid/diet management, AND at least 1 anti‐cholinergic drug (unless participant was contra‐indicated for anti‐cholinergic use). Symptoms of OAB for at least 6 months

Exclusion criteria: Dysfunctional voiding symptoms unrelated to OAB, such as clinically significant bladder outlet obstruction, and urinary retention (pvr > 100 cc). Morbidly obese, defined as having BMI > 40 kg/m2. Stress predominant MUI. Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and uncontrolled epilepsy. Pelvic surgery (such as sub‐urethral sling, pelvic floor repair) within the past 6 months. Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 12 months. Any neuromodulation therapy for OAB within the past 3 months. Failure to respond to previous neuromodulation therapy for OAB. Leading edge of any vaginal prolapse beyond hymenel ring. Prior peri‐urethral or transurethral bulking agent injections for bladder problems within the past 12 months. Any skin conditions affecting treatment or assessment of the treatment sites. History of lower back surgery or injury that could impact placement of the patch, or where underlying scar tissue or nerve damage may impact treatment. Presence of an implanted electro‐medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the lower back. Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study. Known latex allergies, or allergies or hypersensitivity to patch materials that will be in contact with the body (e.g. hydrogel, acrylic‐based adhesive, polyurethane). Uncontrolled diabetes and/or diabetes with peripheral neuropathy. Current UTI or history of recurrent UTIs (> 3 UTIs in the past year). History of lower tract genitourinary malignancies within the last 6 months or any previous pelvic radiation. Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study

Interventions

A (n = 80) 1 VERV electrode patch worn per week for 12 weeks

B (n = 83) 1 sham electrode patch worn per week for 12 weeks

Outcomes

Change in urgency (urinary) incontinence episodes per day (median (IQR), N):

A ‐3.7 (‐4.7 to ‐1.0), 68. B ‐1.7 (‐3.3 to ‐1.0), 75. P = 0.2191)

Change in urinary frequency per day (median (IQR), N):

A ‐1.0 (‐2.7 to 0.3), 80. B ‐1.3 (‐3.0 to ‐0.3), 83. P = 0.2893

Change in volume per void (mL) (median (IQR), N):

A 1.0 (‐26.6 to 23.5), 80. B 8.8 (‐24.3 to 33.3), 83. P = 0.3387

Change in urgency episodes (median (IQR), N):

A ‐1.7 (‐3.3 to 0.3), 80. B ‐1.7 (‐3.3 to 0.3). P = 0.6557

Change in OAB‐symptom composite score (median (IQR), N):

A ‐5.8 (‐14.7 to 1.3), 80. B ‐8.0 (‐15.3 to 0.3), 83. P = 0.4354

Change in OAB‐Q score (median (IQR), N):

A 8.8 (1.6 to 20.0), 56. B 9.2 (‐0.8 to 27.2), 66. P = 0.9918

Percentage of participants with improvement in severity according to Patient Perception of Bladder Condition scale:

A 53.7% of 80 (43/80). B 44.2% of 83 (37/83)

Percentage of participants with overall improvement according to Treatment Benefit Scale:

A 55.4% of 56 (31/56). B 42.4% of 66 (28/66)

Percentage of participants with Improvement as measured by Overactive Bladder Satisfaction With Treatment Questionnaire:

A 65.3% of 32 (21/32). B 57.6% of 34 (20/34)

Percentage of participants improved as measured by clinicians using Clinical Global Impressions:

A 23.2% of 80 (19/80). B 24.2% of 83 (20/83)

Participants with adverse effects:

A 30/80. B 29/82

Notes

Emailed study author asking for means (SDs) 6 January 2015

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Allocation: randomized"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

"Masking: Double Blind (Subject, Investigator)"

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Masking: Double Blind (Subject, Investigator)"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential dropout. Adequate explanation for withdrawals

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: Russia

Period: 2008‐2010

Details of sample size calculation: not reported

Follow‐up: 1‐month's treatment, 12 months’ follow‐up

Participants

N: 229 randomised, 208 analysed at 12 months

Mean (SD) age: 66.3 (range 65‐77)

Sex: women

Inclusion criteria: elderly women with urodynamic impairments and clinically confirmed OAB

Exclusion criteria: not reported

Interventions

All groups: trospium 60 mg + solifenacin 40 mg for 6 weeks then one of the following, beginning 2.5 months after end of drug treatment:

A (n = 59) drugs: trospium 60 mg + solifenacin 40 mg for a month

B (n = 51) detrusor ES: an active electrode (50‐70 cm²) above the pubis, and a passive electrode (150 cm²) in lumbosacral area, diadynamic current, frequency 20 Hz, modulation depth 50%‐75%, intensity 20–40 mA, exposure 15 min, a course consisting of 15 procedures every other day

C (n = 63) conservative treatment: laseropuncture by helium‐neon laser (632.8 nm) at acupuncture points RP 6, RP 9, VC 2 within 1‐1.5 min for each point every day, light guide output power, 2 mW, 25 procedures

D (n = 56) placebo

Outcomes

Daily urinary incontinence episodes (mean, SD, N)

6 months: A 1.1 (0.7), 59. B 2.2 (0.9), 51. C 3.8 (0.8), 63. D 2.7 (1.1), 56

12 months: A 1.5 (0.9), 59. B 3.7 (1.3), 51. C 5.5 (1.4), 63. D 4.8 (2.4), 56

Volume at FDV, mL (mean, SD, N):

6 months: A 289.3 (37.6), 59. B 297.0 (45.3), 51. C 254.5 (49.1), 63. D 279.7 (54.8), 56

12 months: A 257.5 (28.9), 59. B 210.9 (28.7), 51. C 199.3 (49.4), 63. D 192.9 (28.9), 56

Volume at maximal desire to urinate, mL (mean, SD, N):

6 months: A 313.7 (47.1), 59. B 334.8 (38.3), 51. C 286.0 (36.6), 63. D 311.5 (51.7), 56

12 months: A 279.9 (33.8), 59. B 251.9 (42.9), 51. C 178.9 (29.0), 63. D 206.3 (SD missing), 56

Maximum bladder pressure, cmH₂O (mean, SD, N):

6 months: A 32.8 (6.0), 59. B 35.4 (9.3), 51. C 38.9 (7.8), 63. D 31.0 (7.9), 56

12 months: A 28.8 (4.7), 59. B 30.9 (4.9), 51. C 29.8 (6.3), 63. D 23.9 (5.4), 56

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"we randomized 229 women"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

14 participants withdrew due to side effects, 2 discontinued due to the lack of an immediate positive effect; and 2 withdrew for reasons unrelated to the treatment course.

Numbers of withdrawals not reported per treatment group.

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: not reported

Period: not reported

Sample size: not reported

Follow‐up: not reported

Participants

N: 45

Sex: women

Mean age: not reported

Inclusion criteria: women with OAB symptoms

Exclusion criteria: not reported

Interventions

A (n = 16) PFMT

B (n = 14) Intravaginal ES. Twelve 30‐min sessions

C (n = 15) Transcutaneous posterior tibial nerve stimulation. Twelve 30‐minsessions

Outcomes

Symptoms of urgency incontinence, defined as "absence, a little, more or less and much"

Notes

No useable data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Methods

Study design: RCT

Setting: China

Follow‐up: 4 weeks’ maximum treatment

Participants

N: 60 randomised

Sex: not reported

Interventions

A (n = 35) vaginal/anorectal ES, 8‐70 mA, 20 min, 20‐30 sessions

B (n = 25) 2 mg tolterodine daily, 2‐4 weeks

Outcomes

Cure rate:

A 13/35. B 10/25

Improved:

A 13/35. B 9/25

Satisfied or fairly satisfied:

A 19/35. B 20/25

Side effects:

Dry mouth: A 1/35. B 20/25

Uroschesis: A 0/35. B 2/25

Constipation: A 1/35. B 6/25

Blurred vision: A 0/35. B 1/25

Notes

Only partial translation available

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomly divided"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not possible to blind participants, other blinding unclear

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Unclear

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential withdrawal

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Department of a Regional Hospital in Perth, Western Australia

Period: not reported

Sample size: 50 participants in each group would be sufficient to give 0.8 power at the 0.05 alpha level for two‐sided alternative. Calculation of sample size was performed using the PASS statistical software (NCSS, Kaysville, Utah, USA). Parameters used in the calculations were derived from Jundt et al and Lamhut.

Follow‐up: 4 weeks

Participants

N: 24 randomised and analysed

Sex: women

Mean age (SD):

A (n =12) 52.1 (17.5)

B (n = 12) 55.1 (15.1)

Inclusion criteria: women, aged 20 years or older, with stress or UUI

Exclusion criteria: altered mental state, urinary incontinence caused by problems other than stress or urge, transient incontinence, or severe disability requiring full assistance with all acts of daily living

Interventions

A (n = 12) PFMT. 12 sessions (3 per week for 4 weeks): 10 sets of 5 contractions with 30‐s rest between each set. Then repeated after an hour.

B (n = 12) ITT plus PFMT. 12 sessions (3 per week for 4 weeks) of 50 pelvic floor contractions followed by ITT with Nemectrodyne 5 stimulator then another 50 contractions. 2 anterior flat electrodes placed over obturator foramen 1.5cm to 2 cm lateral to symphysis, 2 posterior electrodes placed medial to ischial tuberosities either side of anus. ITT was at highest tolerable frequency between 0‐100 Hz for 15 min (session 1), then 30 min for sessions 2‐12

Outcomes

Pelvic floor muscle strength measured with perineometer (mean, SD, N):

A 9.55 (3.50), 12. B 8.08 (4.83), 12

Pad test (g) (mean, SD, N):

A 1.25 (1.76), 12. B 9.00 (29.3), 12

Frequency (number of micturitions per day) (mean, SD, N):

A 6.29 (2.2), 12. B 7.24 (2.62), 12

Nocturia (number of nocturia episodes per night) (mean, SD, N):

A 0.45 (0.86), 12. B 0.99 (1.04), 12

Change in pelvic floor muscle strength (mean, SD, N):

A 2.03 (2.10), 12. B 2.04 (2.47), 12. (P = 0.253)

Change in pad test (g) (mean, SD, N):

A ‐4.33 (8.37), 12. B ‐85.1 (150), 12. (P = 0.101)

Change in frequency (mean, SD, N):

A ‐0.07 (1.76), 12. B ‐1.81 (1.62), 12. (P = 0.006)

Change in nocturia (mean, SD, N):

A ‐0.49 (0.89), 12. B 0.86 (1.14), 12. (P = 0.199)

No improvement in stop/start test, defined as change from unable to stop to being able to slow, or change from able to slow to able to stop:

A 9/12. B 6/12 (P = 0.2)

No improvement in urgency (not defined):

A 8/12. B 4/12

Notes

We contacted the main author of the study to clarify methodological aspects of the study and request further information. Awaiting reply

No useable data. Not stratified by stress/urgency incontinence

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Participants were randomly allocated as soon as they gave written consent, using the sealed envelope method".

Allocation concealment (selection bias)

Unclear risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants were not blinded due to the nature of the interventions but unclear if this would have effect on outcomes

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Only the assessor but not the patients could be blinded."

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: USA

Period: not reported

Sample size: not reported

Follow‐up: 5 weeks’ treatment then another 5 weeks’ treatment if improvement observed after first 5 weeks, then follow‐up six months after end of 10 weeks’ treatment

Participants

N: 42 recruited, 37 randomised and analysed

Mean (SD) age: 61 (17)

Sex: women

Inclusion criteria: DO

Exclusion criteria: not reported

Interventions

A (n = 18) ES once a week for 5 weeks

B (n = 19) ES twice a week for 5 weeks

Medicon MS‐210 with vaginal and anal probes

Outcomes

Incontinence episodes after 5 weeks (mean, N): 12 (37)

Participants not improved after 5 weeks (N): 0

Participants satisfied enough to request no further treatment:

25% (9)

Adverse effects:

Discomfort: 16% (6/37)

Leg tremor: 8% (3/37)

UTI: 8% (3/37)

Notes

Data not presented by treatment – not useable

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"Randomized into two treatment groups"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding of participants not possible. Other blinding not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

5/42 participants withdrew before treatment; no explanation reported. All participants treated included in analysis. No withdrawals due to adverse effects

Methods

Study design: RCT

Setting: Chile

Follow‐up: 12 weeks’ treatment

Participants

N: 56 randomised

Sex: women

Age: not reported

Inclusion criteria: OAB according to ICI 2002 definition

Exclusion criteria: not reported

Interventions

A (n = 28?) transcutaneal tibial nerve stimulation, twice a week with at least 48 h intervals for 12 weeks

B (n = 28?) long release oxybutynin 10 mg

Outcomes

Frequency (mean? range, N):

A 4 (2‐7), 28. B 8 (1‐13), 28

Urgency (mean? range, N):

A 4 (1‐6), 28. B 7 (4‐15), 28

Urgency incontinence (mean? range, N):

A 2 (0‐3), 28. B 6 (1‐11), 28

Daily pads (mean? range, N):

A 0 (0‐3), 28. B 4 (3‐6), 28

Notes

Numbers randomised to each group not reported, assume equal numbers

Table does not state if means or medians are reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"the randomization was made by permuted blocks"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not possible to blind participants

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: Brazil

Period: not reported

Sample size: not reported

Follow‐up: 4 weeks

Participants

N: 43 randomised

Mean (SD) age: not reported

Sex: women

Inclusion criteria: OAB

Exclusion criteria: not reported

Interventions

A (n = ?) ES 30 min, twice per week for 4 weeks TENS, biphasic with 200 ms pulse duration, 10 Hz frequency, variation of intensity and frequency through one channel and two electrodes.

B (n = ?) unclear if sham or no active treatment: "same protocol but without electrical stimulation."

Outcomes

Daytime frequency: difference between groups P = 0.0001 (in favour of intervention)

Nocturia: difference between groups P = 0.0186 (in favour of intervention)

Improvement in SUI: difference between groups P = 0.0273 (in favour of intervention)

Urgency symptoms: difference between groups P = not significant

Participants with no involuntary detrusor contraction: A 4/?. B 5/?

Notes

No useable data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomized’ ‘divided into two different groups"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Unclear how many participants included in analysis

Methods

Study design: RCT

Multicentre or single‐centre: multi‐centre

Setting: UK

Period: not reported

Sample size: not reported

Follow‐up: 4 weeks

Participants

N: 74 randomised, 64 analysed

Mean (SD) age: not reported

Sex: men and women

Inclusion criteria: ≥ 18 years, OAB symptoms ≥ 6 months, failure of OAB therapies such as behaviour modification and failure of ≥ anti‐cholinergic drug for OAB.

Exclusion criteria: not reported

Interventions

Patient‐managed neuromodulation system (PMNS): transdermal amplitude‐modulated signal through a patch applied to the skin, controlled by wireless handheld remote control. Patch worn for 4 weeks, placed by investigator initially.

A (n = 30) Investigator placement group. Participants returned every 7 days for patch removal and placement of a new patch on contra‐lateral side.

B (n = 34) Subject placement group. Participants returned on day 7 for investigator observation of patch self‐placement and replaced patch at home for the remaining 2 weeks.

Outcomes

UUUI episodes (mean, SD, N):

2.2 (2.5), 64.

% change from baseline in UUI episodes (mean, SD, N):

‐2.7% (3.1), 64.

Change from baseline in UUI episodes (mean, SD, N):

‐47.8 (60.6), 64.

Voiding frequency (mean, SD, N):

9.4 (2.7), 64.

% change from baseline in voiding frequency (mean, SD, N):

‐1.9% (2.5), 64.

Change from baseline in voiding frequency (mean, SD, N):

‐15.0 (19.1)

Volume per void (mean, SD, N):

187.6 (75.0), 64.

% change from baseline in volume per void (mean, SD, N):

8.2% (46.7), 64.

Change from baseline in volume per void (mean, SD, N):

7.5 (26.4), 64.

Urgency episodes (mean, SD, N):

7.8 (3.3), 64.

% change from baseline in urgency episodes (mean, SD, N):

‐2.2 (2.8), 64.

Change from baseline in urgency episodes (mean, SD, N):

‐21.2 (28.6), 64.

Notes

Not useable – results not presented per treatment group

Contacted study author requesting data per group 17 February 2015. Author responded "The device has been withdrawn. Probably doesn’t need to be in the review."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"subjects were randomized"

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not possible to blind participants.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No explanation reported for withdrawals. Data not presented per treatment group.

Methods

Study design: RCT

Multicentre or single‐centre: single‐centre

Setting: Brazil

Period: February–June 2008

Sample size: "Pocock formula, with 47% of neurogenic OAB prevalence and decrease of 30% after treatment"

Follow‐up: 45 days’ treatment, 12 months’ follow‐up

Participants

N: 24 randomised and analysed

Mean (SD) age: A 65.1 (3.6). B 56.1 (10.9)

Sex: men

Inclusion criteria: ≥ 18 years with neurogenic OAB, with stroke occurring between 6 months and 3 years before recruitment

Exclusion criteria: implanted cardiac pacemaker, UTI, bladder cancer, pre‐existing urinary incontinence before stroke, or surgery in the urogenital region

Interventions

A (n = 12) ES of posterior tibialis nerve. Negative electrode was placed on the medial malleolus, and the positive electrode was placed 10 cm above the negative electrode, also on the medial side. The rhythmic flexion of the second toe during the stimulation determined the correct position of the negative electrode. The intensity level was set below the threshold that causes motor contraction because the participant should be comfortable and no pain should occur during the procedure. ES of the posterior tibialis nerve was performed for 30 minutes twice weekly over 12 sessions (45 days), with a frequency of 10 Hz and a pulse width of 200 µs in continuous mode.

B (n = 12) no active treatment for OAB. 12 stretching sessions of the lower limbs

Outcomes

Participants with no improvement in OAB symptoms:

12 months: A 0/12. B 9/12

Participants with urinary urgency:

45 days: A 7/12. B 10/12

12 months: A 6/12. B 9/12

Participants with UUI:

45 days: A 8/12. B 9/12

12 months: A 7/12. B 8/12

Participants with nocturnal enuresis:

45 days: A 0/12. B 2/12

12 months: A 0/12. B 2/12

Participants with nocturia:

45 days: A 5/12. B 9/12

12 months: A 1/12 B 6/12

Participants with increased daytime frequency:

45 days: A 3/12. B 11/12

12 months: A 0/12. B 9/12

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

All participants were numbered sequentially from 1‐24 and divided into 2 groups of 12 assigned to the treatment group

Allocation concealment (selection bias)

Unclear risk

All participants were numbered sequentially from 1‐24 and divided into 2 groups of 12 assigned to the treatment group

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported. Impossible to blind participants

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All randomised participants included in analysis. One dropout. "One patient in the placebo group died after treatment, but was analyzed as if improved."

Methods

Study design: RCT

Multicentre or single‐centre: not reported

Setting: UK

Period: not reported

Sample size: the study was powered to detect a 3‐point (common standard deviation of 6) between‐group difference on the ICIQ‐UI (scale of 0‐21) with 80% power at a 5% level of significance.

Follow‐up: 12 weeks

Participants

N: 124 randomised, 97 analysed

Mean (SD) age: A 47.9 (8.9). B 48.2 (8.6)

Sex: women

Inclusion criteria: women, 18–65 years with self‐reported SUI, UUI, or MUI

Exclusion criteria: Pregnancy or a baby in the last 3 months. Recent abdominal surgery and previous or current active therapy for pelvic malignancy. Implanted pacemaker. Manual dexterity insufficient to place the device. Previous treatment for incontinence (including supervised PFME. Presence of a neurological condition such as multiple sclerosis or Parkinson’s disease

Interventions

A (n = 64) ES. Pelviva device inserted like a tampon into the vagina. The stimulation programme was delivered using a duty cycle of 10‐sstimulation followed by 10‐s rest that runs for a period of 30 min, pre‐programmed to automatically gradually ramp‐up the intensity of stimulation over a 24‐s period to reach a therapeutic level and switch off automatically after 30 min. During the 10 seconds 'on time' the device delivered 10 repeats of a short high intensity burst of 50 Hz stimulation immediately preceded by a doublet (125 Hz), superimposed on continuous low frequency 2 Hz stimulation.

Plus standardised advice about how and when to undertake PFME. These included 10 slow and controlled squeezing and lifting contractions and 10 quick contractions each repeated 3‐4 times a day

B (n = 60) unsupervised conservative treatment (no active treatment). Standardised advice about how and when to undertake PFME. These included 10 slow and controlled squeezing and lifting contractions and 10 quick contractions each repeated 3–4 times a day.

Outcomes

Participants with no improvement in symptoms (i.e. same or worse ICIQ score):

A 9/49. B 14/46

*A UUI 5/50. B 6/47.

*A MUI 8/50. B 19/47.

*A UUI+MUI 13/50. B 25/47

Participants with SUI, UUI or MUI

A 94% (i.e. 46/49) B 100% (i.e. 46/46)

International Consultation on Incontinence Questionnaire – Urinary Incontinence (ICIQ‐UI) score (higher score is increased severity) (median, range, N):

A 6 (0‐17), 49. B 9 (3‐18), 46

Leak frequency (0‐5 scale, higher score is more leaks) (median, range, N):

A 1 (0‐4), 49. B 2 (1‐4), 46

Leak interference (0‐10 scale, higher score is more interference) (median, range, N):

A 3 (0‐10), 49. B 4 (0‐10), 46

Leak amount (0‐6 scale, higher score is greater amount) (median, range, N):

A 2 (0‐6), 49. B 2 (2‐4), 46

Adverse effects: A 0/49. B 0/46

Notes

*Outcome data not separated by SUI/UUI/MUI – contacted study author 3 February 2015, replied with supplementary data.

Femeda, the company responsible for developing and producing the Pelviva device was the trial sponsor. The sponsor was responsible for developing the Pelviva device, was the funder of the study, and was engaged in the development of the trial design. The sponsor has provided full access to the data and is fully informed of this publication process. The primary author (J.O.) takes full responsibility for the integrity of the data and accuracy of the data analysis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"subjects were assigned by a simple computer generated AB randomization list to either the exercise or Pelviva group."

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

"Participants could not be blinded to the treatment group and were aware of the study hypothesis. Every care was taken to ensure the assessor remained blind to treatment allocation and participants were advised not to discuss their treatment with them."

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"the assessor remained blind to treatment allocation"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No differential dropout. No explanations for withdrawals

Methods

Study design: RCT

Multicentre or single‐centre: single

Setting: Spain

Period: not reported

Details of sample size calculation: no previous data available for power calculation

Follow up: 12 weeks

Participants

N: 24 randomised, 22 analysed

Mean (SD) age: 60 (14.4)

Sex: women

Inclusion criteria: urgency incontinence, either men or women, 45‐75 years, moderate‐severe on ICIQ‐SF and CACV, previous conservative treatment, at least 1 year of incontinence, willing to participate

Exclusion criteria: neurological damage to tibial nerve, diseases of central nervous system, previous incontinence surgery, pacemaker, not well‐controlled cardiac disease, pregnancy, important venous disease in the lower limbs, skin problems in lower limbs that would impede acupuncture, treatment with oral anticoagulants, acute infectious processes, psychiatric or cognitive impairments

Interventions

AWQ‐104L Digital. 20 Hz, 320 μs. Square wave, current 0‐10 mA. 30 mm x 1.5” needle

A (n = 12) electrostimulation with SP 6 Sanyinjiao

B (n = 12) percutaneous tibial nerve stimulation

Outcomes

Micturitions per day (mean (SD) N)

A 7.73 (1.67), 11. B 8 (1.73), 11

Nocturia episodes (mean (SD), N)

A 2.09 (1.92), 11. B 1.09 (1.51), 11

Urgency episodes per 24 h (mean (SD) N)

A 5.09 (3.42), 11. B 3.09 (2.21), 11

Incontinence episodes per 24 h (mean (SD), N)

A 4.55 (4.03), 11. B 1.64 (1.91), 11

B‐SAQ score score (mean, SD, N)

Symptoms: A 7.82 (1.83), 11. B 5.09 (2.17), 11

Complaints/problems: A 7.27 (2.24), 11. B 5.18 (2.56), 11

ICIQ‐SF score (mean (SD), N)

A 7.27 (2.24), 11. B 5.18 (2.56), 11

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation table

Allocation concealment (selection bias)

Low risk

Allocation carried out centrally by member of research team not involved in the intervention

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants can’t be blinded

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors blinded – had no involvement in carrying out intervention

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No differential attrition

Methods

Study design: RCT

Period: January 2010 and April 2011

Setting: not reported

Sample size: not reported

Follow‐up: 12 weeks’ treatment

Participants

N: 30 randomised

Sex: not reported

Age: not reported

Inclusion criteria: people OAB in whom all conventional therapies had failed

Exclusion criteria: not reported

Interventions

A: percutaneous posterior tibial nerve stimulation

B: anticholinergic agent

C: PTNS plus anticholinergic agent

Outcomes

A (n = not reported) percutaneous posterior tibial nerve stimulation

B (n = not reported) anticholinergic agent

C (n = not reported) PTNS plus anticholinergic agent

Notes

Urinary Distress Inventory (UDI‐6)

Incontinence Impact Questionnaire (IIQ‐7)

Over Active Bladder symptom scores (OABSS)

"there was a statistically significantly higher improvement in PTNS and PTNS + ACA groups when compared to group 2" (B: anticholinergic agent alone)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"randomly divided into 3 groups."

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Methods

Study design: RCT

Multicentre or single‐centre: 11 centres in the USA

Setting: not reported

Period: June 2006‐September 2008

Sample size: the sample size used to support this analysis was based on the assumptions of significance level of 5%, power of 80%, and expected mean reduction in voids of 1.8 for tolterodine and 3.6 for PTNS based on previously published efficacy data. Secondary end points were analysed using 2‐sided t tests with 95% CI. An independent biostatistician performed all analyses using SAS® Version 9.2. All voiding diary data were sent to the biostatistician for compilation and analysis.

Follow‐up: 12 weeks

Participants

N: 100 randomised, 85 analysed

Mean (SD) age: A 57.5 (15.2); B 58.2 (11.3)

Sex: 94 women, 6 men

Inclusion criteria: adults with OAB symptoms, with or without a history of previous anticholinergic drug use, with at least 8 voids per 24 h documented by history and physical and voiding diary.

Exclusion criteria: OAB pharmacotherapy within the previous month, primary complaint of SUI, demonstrated sensitivity to tolterodine or its ingredients, pacemakers or implantable defibrillators, excessive bleeding, urinary or gastric retention, nerve damage or neuropathy, uncontrolled narrow angle glaucoma, positive urinalysis for infection or pregnancy, or current pregnancy or planning to become pregnant during the trial

Interventions