Primary Outcome Measures:
- How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Satisfaction with surgery at 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Return to usual activities and usual sex life after surgery? [ Time Frame: 6 weeks and 1 year ] [ Designated as safety issue: No ]
- The prevalence of voiding dysfunction at 12 months postoperatively? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Surgical complications, both short term and long term? [ Time Frame: 6 weeks and 1 year ] [ Designated as safety issue: Yes ]
- Utility and cost? (an economic evaluation) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
This study is a randomized trial in which women with stress incontinence will be allocated to receive either TOT or TVT procedures. Women who elect surgical management of their type II stress incontinence are eligible to participate in the trial. Baseline data, including a patient questionnaire, will be collected. Hospital outcomes, including length of stay and surgical complications will be documented from hospital charts. All women attend a 6-week follow-up visit as standard of care: a structured data collection form will be used by surgeons to collect information and another patient questionnaire will be administered. At 12 months postoperatively women will attend clinic for objective measurement of incontinence, a full exam and to complete a questionnaire. The main outcome is effectiveness of the procedure determined using a 1-hour pad test. Secondary research questions include:
How effective is TOT compared to TVT in terms of:
Subjective cure at 12 months postoperatively? Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? Satisfaction with surgery at 12 months postoperatively? Return to usual activities and usual sex life after surgery? The prevalence of voiding dysfunction at 12 months postoperatively? Surgical complications, both short term and long term? Utility and cost? (an economic evaluation) The study will be carried out according to the ICH Good Clinical Practice Guidelines.