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

Phase 3TerminatedNCT00685217

University of Calgary74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Incontinence, Stress

Interventions

TVT Secur (Gynecare)PROCEDURE

Sling device for stress urinary incontinence

TVT (Gynecare)PROCEDURE

Sling procedure for stress urinary incontinence

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (4)

Foothills Medical Centre

Calgary, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Penticton Regional Hospital

Penticton, British Columbia, Canada

Lions Gate Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test