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

Phase 3

Terminated

• Conditions: Urinary Incontinence, Stress
• Interventions: Procedure: TVT Secur (Gynecare); Procedure: TVT (Gynecare)

• Registration Number: NCT00685217
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2011-03
• Study Completion: 2012-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TVT Secur surgical device	TVT Secur (Gynecare)	Single incision tape device
TVT surgical device	TVT (Gynecare)	Usual care retropubic tape device

Primary Outcome Measures

Name	Time	Method
Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test	12 months following surgery

Secondary Outcome Measures

Name	Time	Method
Satisfaction with surgical outcome	12 months following surgery	Patients will be asked about the expectations they had before surgery, and asked if the outcome had met expectations. Women will be asked about satisfaction with the surgical outcome, if they would have the same operation again under the same circumstances, and if they would recommend the same operation to someone else with the same problem.
Cost	up to 12 momths following surgery
Utility (15-D)	6 weeks and 12 months following surgery
Incontinence-related quality of life (UDI-6, IIQ-7)	6 weeks and 12 months following surgery
Return to usual activities	up to 12 months following surgery
Surgical complications	up to 12 months following surgery
Subjective evidence of cure	12 months following surgery
Sexual function (PISQ-12)	12 months following surgery
Voiding dysfunction	12 months following surgery

Trial Locations

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