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

University of Calgary

Status and phase

Terminated

Phase 3

Conditions

Urinary Incontinence, Stress

Treatments

Procedure: TVT (Gynecare)

Procedure: TVT Secur (Gynecare)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00685217

21528

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

Female

Volunteers

No Healthy Volunteers

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