Goode 2003.

Methods	Study design: RCT Multicentre or single‐centre: unclear Setting: USA Period: October 1995 – May 2001 Details of sample size calculation: a sample size of 200 was selected to allow detection of 15% differences in reduction of episodes on bladder diary between treatment groups with 85% power and a significance level of 0.05, assuming a 2‐sided hypothesis test and a pooled within‐group SD of 20%. Follow‐up: 8 weeks' treatment
Participants	N: 200 randomised and analysed Mean (SD) age: A ‐ 57.7 (10.0) years; B ‐ 54.9 (9.4) years; C ‐ 55.9 (10.1) years Inclusion criteria: community‐dwelling women, 40 years or older, ambulatory, and describe a pattern of predominantly stress incontinence occurring at least twice per week and persisting for at least 3 months. Stress incontinence had to be the predominant pattern (i.e. the number of stress episodes had to exceed the number of urge and other episodes). Stress incontinence had to be objectively demonstrated during urodynamic testing. Exclusion criteria: continual leakage, postvoid residual urine volume greater than 150 mL, severe uterine prolapse (past the vaginal introitus), decompensated congestive heart failure, haemoglobin A1C ≥ 9, or impaired mental status (Mini‐Mental State Examination score > 24).
Interventions	A (n = 66) ‐ behavioural training. 4 clinic visits at 2‐week intervals. During visit 1, anorectal biofeedback (session lasting approx. 20 min) was used to help patients identify pelvic floor muscles and teach them how to contract and relax these muscles. Patients received verbal and written instructions for 3 sessions of pelvic floor muscle exercises daily. Each session consisted of 15 repetitions of 2‐to 4‐second contractions with equal periods of relaxation. The initial duration of each individual contraction was determined based on the ability demonstrated by the patient in the training session. Patients were advised to do 1 session lying, sitting, and standing, and whenever possible to integrate the exercises into other daily activities. Once daily they were to practice interruption or slowing of the urinary stream during voiding. During visits 2, 3, and 4, the home exercise regimen was adjusted by gradually increasing the duration of each contraction to a maximum of 10 seconds, with an equal period of relaxation between contractions. B (n = 67) ‐ electrical stimulation plus behavioural training. ES with home unit (Hollister InCare, Libertyville, Ill) programmed to deliver stimulation via vaginal probe with: biphasic pulses (frequency of 20 Hz), pulse width of 1 ms, and pulse train to rest period of 1:1. The current intensity was adjusted by the patient to the maximum level she could tolerate comfortably, up to 100 mA. Simultaneous with each muscle contraction induced by PFES, patients performed a voluntary pelvic floor muscle contraction. Patients were instructed to use the PFES unit for 15 min every other day. On alternate days, to keep the exercise time consistent between groups, patients were instructed to perform 3 sessions of pelvic floor muscle exercises (as in the behavioral training group). C (n = 67) ‐ control group. Self‐administered behavioural training. Booklet provided with written instructions for an 8‐week self‐help behavioral programme that was based on the behavioural training program described above but was completely self‐administered, without benefit of professional expertise or equipment.
Outcomes	N with improvement in SUI (subjective description of treatment outcome 'better' or 'much better') N 'somewhat' or 'completely' satisfied N with fewer incontinence episodes (subjective assessment) N reporting smaller episodes (subjective assessment) N wearing less protection Incontinence no longer restricts activities Incontinence episodes per week % reduction in incontinence episodes per week Objectively measured continence Adverse effects
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Within each stratum (stratified by self‐identified race), patients were randomized using a block size of 6 to ensure equity in group size. The randomization schedule was computer‐generated by the biostatistician and implemented by the nurse practitioners. "Stratification procedures were used at randomization to ensure that groups had similar types and severity of incontinence and race distribution (black or white)"
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not possible to blind participants or providers
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	A: 12/66 withdrew (7 directly related to intervention) B 8/67 withdrew (2 directly related to intervention) C 25/67 withdrew (5 directly related to intervention) Adequate explanations for withdrawals. All participants who were randomised were included in primary analysis.
Selective reporting (reporting bias)	Low risk	All outcomes seem to be reported in full
Other bias	Low risk	Nothing to indicate any other source of bias