A study comparing pelvic floor muscle exercises with and without the use of computer feedback for women with urine leakage (OPAL)

INTERVENTION: 1. PFMT intensified with use of electromyography biofeedback both at home and in clinic. 2. Basic PFMT. Both groups will be seen for six appointments and intervention over a 16 week period. Follow up, with questionnaires at 6,12 & 24 months and interviews for a sub‐group of approximately 40 women. Assessors carrying out the 6‐month pelvic floor muscle assessment will be blinded to which group the woman is in. CONDITION: Female stress or mixed urinary incontinence ; Urological and Genital Diseases ; Stress incontinence PRIMARY OUTCOME: International Consultation on Incontinence short form questionnaire (ICIQ‐UI SF) measured at baseline, 6, 12 and 24 months SECONDARY OUTCOME: Urinary outcomes; 1. Number of episodes of UI per day, recorded by women in a bladder diary [Locher et al 2001]; 2. Impression of global improvement in UI (PGI‐I) [Yalcin and Bump 2003]; 3. Number of women with UI cured and number with UI improved, derived from the ICIQ‐UI ShortForm (cured is a negative response to both 'how often do you leak urine?' and 'how much urine do you usually leak (whether you wear protection or not)?'; 4. Uptake of surgery for UI; 5. Uptake of other treatment for UI; 6. Other urinary symptoms (ICIQ‐FLUTS) [Brookes et al 2004]; ; Quality of life outcomes; 1. UI‐specific quality of life (Kings Health Questionnaire) [Kelleher et al 1997]; 2. General health (EQ‐5D‐3L) [EuroQol Group]; ; Pelvic floor related outcomes; 1. Prolapse symptoms (POP‐SS ‐ Hagen et al 2009); 2. Bowel symptoms (early version of ICIQ Bowel Short Form); 3. Pelvic floor muscle function (Oxford scale ‐ Laycock 2008, ICS method ‐ Messelink et al 2005); 4. Self‐efficacy for PFMT (PFME self‐efficacy scale) [Chen 2004]; 5. Adherence to PFMT (exercise diary/follow‐up questionnaire); ; Economic outcomes; 1. Cost and use of NHS services; 2. Cost to the women and their families/carers; 3. The incremental costs, QALYs and incremental cost per QALY derived by the economic model. INCLUSION CRITERIA: 1. Women 18 years of age or above, presenting with a new episode of stress or mixed urinary incontinence (UI) 2. Who are willing and eligible to be randomised