Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

Study Overview
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Brief Summary
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Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.

Detailed Description
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The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT® at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence. The primary aims are: In stress continent women planning vaginal surgery for pelvic organ prolapse: To determine if the failure rate defined by subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence [defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory (PFDI) incontinence items] differs between vaginal prolapse repair and vaginal prolapse repair plus TVT® during the first 3 months after the index surgery. To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®, whether or not there was subsequent treatment for symptoms of urinary incontinence; i.e., to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT® at the time of the prolapse surgery. To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery.

Official Title
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Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: TVT
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI: Do you usually have a sensation of bulging or protrusion from the vaginal area? Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm). Surgical plan that includes a vaginal approach for apical or anterior prolapse repair. Able and willing to complete data collection per protocol, including written informed consent. Exclusion Criteria: Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence. Untreated urinary tract infection (may be included after resolution). Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items: Do you usually experience urine leakage related to coughing, sneezing, or laughing? Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis? Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tension-free Vaginal Tape (TVT) surgery | Device: TVT<br>* Prophylactic TVT<br>|
| Sham Comparator: 2<br>Sham Tension-free Vaginal Tape (TVT) surgery | Other: Sham<br>* Sham TVT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence | Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided. | 3 months post-surgery | 
| Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery | Defined as a positive cough stress test or report of bothersome incontinence symptoms. | 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study 36-Item Short Form Health Survey | This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up. | Baseline, 3 months, and 12 Months post-surgery | 
| Positive Cough Stress Test | A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml. | 3 and 12 Months Post-surgery | 
| Symptoms of Incontinence | Symptoms that were at least moderately bothersome to the participant (as measured by a response of moderately or quite a bit to any of the four items on the Pelvic Floor Distress Inventory regarding leakage). | 3 and 12 Months Post-surgery | 
| Treatment for Incontinence | The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence. | 3 months post-surgery | 
| Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) | PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up. | Baseline, 3 months, and 12 months post-surgery | 
| Urinary Distress Inventory (UDI) Obstructive Symptom Subscale | Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up. | Baseline, 3 months, and 12 months post-surgery | 
| Urinary Distress Inventory (UDI) Irritative Symptom Subscale | Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up. | Baseline, 3 months, and 12 months post-surgery | 
| Urinary Distress Inventory (UDI) Stress Subscale | Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up. | Baseline, 3 months, and 12 months post-surgery | 
| Incontinence Severity Index | Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline. | Baseline, 3 months, and 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prolapse, Urinary incontinence, TVT