A randomised trial of transvaginal tape (TVT) versus transvaginal obturator tape (TVTO): a pilot study

INTERVENTION: This is a pilot single centre un‐blinded randomised controlled trial with a 12 month follow‐up. Randomisation is independently prepared numbered opaque sealed envelopes stored independently from the trial office. Patients will be randomised to one of the following: 1. Experimental treatment: transvaginal obturator tape (TVTO) 2. Control treatment: transvaginal tape (TVT) Patients were consented on admission to hospital but had previously received verbal information and written information leaflet at the urodynamic clinic or via post and again on admission to the ward. Women were randomised to one of the two procedures once consent had been obtained. The two interventions were performed as described by the manufacturing company, Gynecare. The operating surgeons were experienced in both forms of surgery and the procedure was performed in an operating theatre under either spinal or general anaesthetic dependant on the patient choice. Women were discharged typically on the day of surgery but discharge was determined by the ability to void a normal amount of urine. CONDITION: Stress urinary incontinence ; Urological and Genital Diseases ; Urinary incontinence PRIMARY OUTCOME: 1. Changes in International Consultation on Incontinence Questionnaire (ICIQ), assessed at baseline; 2. Differences in quality adjusted life years (QALYs) estimated from responses to the EQ‐5D, measured at baseline and 12 months SECONDARY OUTCOME: 1. Subjective cure rate; 2. Changes in the King's Health questionnaire (KHQ) scores; 3. Difference in EQ‐5D scores at three and twelve months follow‐up; 4. Operative data; 5. Self‐reported acceptability; 6. Usage recommendation to a friend; ; All measured at baseline, two weeks (except for the EQ‐5D), three months and twelve months. INCLUSION CRITERIA: 1. Women aged over 18 years 2. Urodynamic stress incontinence 3. Failed conservative treatment 4. Being offered surgery