Background

ObjectiveTo assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.DesignParallel group randomised controlled trial.Setting23 community and secondary care centres providing continence care in Scotland and England.Participants600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.InterventionsParticipants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.Main outcome measuresThe primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women’s perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.ResultsMean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference −0.09, 95% confidence interval −0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), −£409 to £651, P=0.64) and quality adjusted life years (−0.04, −0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.ConclusionsAt 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.Trial registrationISRCTN57756448.

before conducting the tests. The database was used to identify women aged 18-80 years who had multichannel cystometry for UI over a 17-year period (1 January 1990 to 31 December 2006). To apply the NICE criterion of a 'clearly defined clinical diagnosis of pure SUI', strict selection criteria were used to identify patients with pure SUI. The reliability of the patients' history in predicting 'pure' urodynamic SUI in patients with 'pure' SUI was investigated. The correspondence of the symptomatic diagnosis of pure SUI with the urodynamic findings was assessed, and sensitivity, specificity, positive and negative predictive values were calculated using contingency tables. RESULTSOnly 324 (5.2%) women had pure SUI; moreover, a quarter of those with pure SUI symptoms ultimately had urodynamic diagnoses other than urodynamic SUI, that could affect the outcome of continence surgery. CONCLUSIONThese findings indicate that only a small group of women fulfil the NICE criteria of pure SUI. These strict criteria do not ensure that all women with potentially important urodynamic findings are evaluated accordingly. Therefore, we suggest that this NICE recommendation was unwise and, furthermore, was not based on properly acquired expert opinion. KEYWORDSurodynamics, stress urinary incontinence, practice guideline Study Type -Diagnostic (opinion) Level of Evidence 5

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