Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT

This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.

Inclusion Criteria:

• Women with stress incontinence, defined as leaking with increased abdominal pressure
• Eligible for both types of surgery

Exclusion Criteria:

Women who:

• Have vaginal prolapse requiring surgical repair
• Have had previous incontinence surgery
• Have overactive bladder or incontinence is caused only by bladder overflow
• Intend to have further children
• Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised
• Are unable to understand English
• Will be unavailable for follow-up