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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Procedure: TVT Secur (Gynecare)
* Procedure: TVT (Gynecare)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TVT Secur surgical device<br>Single incision tape device | Procedure: TVT Secur (Gynecare)<br>* Sling device for stress urinary incontinence<br>|
| Active Comparator: TVT surgical device<br>Usual care retropubic tape device | Procedure: TVT (Gynecare)<br>* Sling procedure for stress urinary incontinence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evidence of cure |  | 12 months following surgery | 
| Incontinence-related quality of life (UDI-6, IIQ-7) |  | 6 weeks and 12 months following surgery | 
| Sexual function (PISQ-12) |  | 12 months following surgery | 
| Satisfaction with surgical outcome | 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. | 12 months following surgery | 
| Return to usual activities |  | up to 12 months following surgery | 
| Voiding dysfunction |  | 12 months following surgery | 
| Surgical complications |  | up to 12 months following surgery | 
| Cost |  | up to 12 momths following surgery | 
| Utility (15-D) |  | 6 weeks and 12 months following surgery |