Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women

Study Overview
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Brief Summary
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Stress urinary incontinence (SUI) is a health concern for many women. The transvaginal tape (TVT) surgery has become a common procedure to address the problem. Another surgery is now available, trans-obturator tape (TOT). The investigators will compare these 2 approaches to dealing with SUI and follow the women for 1 year. Women will also be followed at 5 years after surgery.

Detailed Description
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This study is a randomized trial in which women with stress incontinence will be allocated to receive either TOT or TVT procedures. Women who elect surgical management of their type II stress incontinence are eligible to participate in the trial. Baseline data, including a patient questionnaire, will be collected. Hospital outcomes, including length of stay and surgical complications will be documented from hospital charts. All women attend a 6-week follow-up visit as standard of care: a structured data collection form will be used by surgeons to collect information and another patient questionnaire will be administered. At 12 months postoperatively women will attend the clinic for objective measurement of incontinence, a full exam and to complete a questionnaire. The main outcome is effectiveness of the procedure determined using a 1-hour pad test. Secondary research questions include: How effective is TOT compared to TVT in terms of: Subjective cure at 12 months postoperatively? Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? Satisfaction with surgery at 12 months postoperatively? Return to usual activities and usual sex life after surgery? The prevalence of voiding dysfunction at 12 months postoperatively? Surgical complications, both short term and long term? Utility and cost? (an economic evaluation) The study will be carried out according to the ICH Good Clinical Practice Guidelines. At 5 years postoperatively women will attend the clinic for a further follow-up. The primary research question of the 5-year follow-up is: Safety - What is the incidence of vaginal erosion or other serious adverse outcomes of surgery among women who had a surgical procedure for stress urinary incontinence utilizing a TOT device, versus a TVT device, over the 5 years following surgery? Secondary questions are as follows: Effectiveness - What are the objective and subjective outcomes of TOT compared with TVT at 5 years following surgery for SUI? Health economics - What are the disease-specific rates of health service utilization related to repeat surgical intervention, as well as surgery and other treatment related to adverse events for women who had a TOT procedure, versus those who had a TVT procedure, over the 5 years after surgery? Using economic modelling and cost utility analysis, is TOT cost-effective compared with TVT over the 5 years after surgery? Other question: Do women with tape found to be palpable in the vagina at 12 months postoperatively, go on to develop vaginal erosion by 5 years following surgery?

Official Title
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Surgical Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial (RCT) of TOT vs TVT

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: TVT Surgery TOT Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with type II stress incontinence, defined as leaking with increased abdominal pressure Are eligible for both types of surgery Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Active Comparator: 1<br>Trans-vaginal tape Surgery | Procedure: TVT Surgery TOT Surgery<br>* TVT surgery and TOT surgery<br>|
| Experimental: 2<br>Trans-obturator tape surgery | Procedure: TVT Surgery TOT Surgery<br>* TVT surgery and TOT surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How effective is TOT compared to TVT in terms of objective cure at 12 months postoperatively? | Objective evidence of SUI will be obtained using a standardised pad test undertaken at 12 months following surgery. The pad test will be carried out using a modification of the International Continence Society (ICS) recommendations. Women will be considered 'cured' if the pad weight gain is less than 1g over the test period. This is the definition of cure used by Ward and will allow comparison with that trial. | 1 year | 
| Vaginal erosion or other serious adverse outcomes of surgery over 5 years postoperatively |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How effective is TOT compared to TVT in terms of subjective cure 12 months postoperatively? |  | 1 year | 
| Incontinence-specific quality of life at 6 weeks and 12 months postoperatively? |  | 1 year | 
| Satisfaction with surgery at 12 months postoperatively? |  | 1 year | 
| Return to usual activities and usual sex life after surgery? |  | 6 weeks and 1 year | 
| The prevalence of voiding dysfunction at 12 months postoperatively? |  | 1 year | 
| Surgical complications, both short term and long term? |  | 6 weeks and 1 year | 
| Utility and cost? (an economic evaluation) |  | 1 year | 
| Subjective effectiveness at 5 years postoperatively |  | 5 years | 
| Incontinence-specific quality of life at 5 years postoperatively | Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) | 5 years | 
| Health care utilization over 5 years postoperatively |  | 5 year | 
| Cost effectiveness over 5 years postoperatively |  | 5 year | 
| Objective effectiveness at 5 years postoperatively | Pad test leakage of <1g over period of test | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incontinence, Surgery, Trans-vaginal tape, Trans-obturator tape