TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

Study Overview
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Brief Summary
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The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.

Detailed Description
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Patient satisfaction will be measured by symptom quality of life questionnaires (pre-operatively, 3 months and one year) and patient pain will be measured by verbal analogue rating scale (post-operative day 1 and day 7). Clinical efficacy will be measured by a cough stress test pre-operatively and post-operatively at 3 months and 1 year. A Q-tip test will also be performed pre-operatively and at 3 months and 1 year post-operatively. Subjects will be followed for a minimum of one year to evaluate recurrence of symptoms and complications, including the rate of mesh erosion, time to normal void in the post-operative period, the rate of sling revision, post-operative pain, voiding dysfunction and de novo urgency.

Official Title
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TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: TVT-Obturator (TVT-O)
* Device: TVT-Secur (TVT-S) (Hammock method)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are at least 18 years of age Demonstrate a positive cough stress test during complex multi-channel urodynamic testing Demonstrate impact of stress urinary incontinence on quality of life questionnaire Are able to comprehend and sign a written informed consent Understand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations Are psychologically stable and suitable for interventions determined by the investigator Are ambulatory and able to use a toilet independently Exclusion Criteria: Patients: Who are pregnant or planning to become pregnant during the study or in the future With a elevated post-void residual (defined as PVR > 100cc) With a bleeding condition or on anti-coagulant therapy With immunosuppression (i.e. HIV, lymphoma) With multiple sclerosis or other progressive neurological disease With evidence of a local or systemic infection, including urinary tract infection With evidence of intrinsic sphincter deficiency as defined by a maximal urethral closure pressure of <20 cm H2O Previous sub-urethral sling Predominant overactive bladder symptoms

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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Accepts Healthy Volunteers

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>TVTO | Device: TVT-Obturator (TVT-O)<br>* sub urethral sling<br>|
| Active Comparator: 2<br>TVTS | Device: TVT-Secur (TVT-S) (Hammock method)<br>* suburethral sling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of TVT-S versus TVT-O suburethral slings in the treatment of stress urinary incontinence or the stress incontinence component of mixed urinary incontinence by the presence or absence or urinary incontinence on cough stress test. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe or assess known side effects or complications,post-operative pain, time of return to daily activities of living, improvement in patient quality of life, change in Q-tip test |  | 1 year |