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| ID | Type | Description | Link |
|---|---|---|---|
| 94021001 |
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| Name | Class |
|---|---|
| Corewell Health West | OTHER |
| Saint Luke's Health System | OTHER |
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I. Specific Aims
Pelvic organ prolapse is a common and distressing condition that is frequently associated with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral colpopexy is the preferred operation for repairing pelvic prolapse. As many as 91% of women with pelvic organ prolapse undergoing sacral colpopexy also experience SUI. In addition, up to 44% of previously continent women develop SUI incontinence after sacral colpopexy: perhaps because a sacral colpopexy may predispose to opening of the bladder neck if secured too tightly. The selection of a surgical procedure to prevent and manage SUI in women undergoing sacral colpopexy is empiric rather than evidence-based. Conceptually, a mid-urethral sling may be more effective than a Burch procedure for preventing urinary leakage because a sling provides outlet resistance beyond the bladder neck and therefore it may compensate for a downward tension on the bladder neck resulting from the sacral colpopexy. Indeed, clinical observations suggest that a mid-urethral sling is effective among women who have persistent urinary incontinence after sacral colpopexy with a Burch procedure. Therefore, the investigators' global hypothesis is that a mid-urethral sling is preferable to a Burch procedure for preventing and improving stress urinary incontinence in women undergoing sacral colpopexy for pelvic organ prolapse. The investigators' SPECIFIC AIMS are to evaluate objective and subjective outcomes at 6, 12 and 24 months in 124 women with urinary incontinence and advanced pelvic organ prolapse. All women will be undergoing a sacral colpopexy and will be randomized to either a Burch procedure or a mid-urethral sling. The primary endpoint is composite continence at 6 months while secondary endpoints will include composite continence and subjective measures of incontinence, patient satisfaction and morbidity associated with these procedures. The investigators' hypotheses are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Burch | Active Comparator | Patients will receive a Burch urethropexy at the time of an abdominal sacral colpopexy. |
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| Mid-urethral sling | Experimental | Patients will receive a mid-urethral sling at the time of an abdominal sacral colpopexy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burch urethropexy | Procedure | Patients will undergo a Burch modified Tanagho procedure (in which the anterior vagina is suspended to Cooper's ligament bilaterally using two non-absorbable sutures). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is to compare the proportion of patients who are continent in each group. Continence requires negative standardized stress test performed by a masked observer; no interim re-treatment for SUI; no self reported incontinence (ISI =0) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is to compare the proportion of patients who have stress specific continence in each group. Stress specific continence requires: fulfilling criteria 1 and 2 above and 3) no self reported SUI specific symptoms. | 6 months | |
| To compared continence, stress specific continence and patient satisfaction between groups at 12 and 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuel C. Trabuco, MD, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38527605 | Derived | Raju R, Madsen AM, Linder BJ, Occhino JA, Gebhart JB, McGree ME, Weaver AL, Trabuco EC. Defining success after surgical treatment of stress urinary incontinence. Am J Obstet Gynecol. 2024 Aug;231(2):235.e1-235.e16. doi: 10.1016/j.ajog.2024.03.034. Epub 2024 Mar 23. | |
| 29215517 | Derived | Trabuco EC, Linder BJ, Klingele CJ, Blandon RE, Occhino JA, Weaver AL, McGree ME, Gebhart JB. Two-Year Results of Burch Compared With Midurethral Sling With Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):31-38. doi: 10.1097/AOG.0000000000002415. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Synthetic mid-urethral sling (TVT) | Procedure | Patients will undergo a polypropylene mid urethral sling as described by the manufacture (Align, Bard Urological, Covington, GA). |
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| 12 and 24 months |
| Compare the safety of the Burch and the mid-urethral sling. | 6, 12 and 24 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |