Comparison of Burch Urethropexy and Mid-urethral Sling Performed Concomitantly With a Sacral Colpopexy
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|ClinicalTrials.gov Identifier: NCT00934999|
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : March 22, 2016
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:
- At 6 months, urinary continence rates will be higher after a mid-urethral than after a Burch procedure. Urine continence will be assessed by composite measure of incontinence: no subjective complaint, no interim treatment, and negative standardized stress test performed by a masked observer. This assessment will be repeated at 12 and 24 months post-operatively to establish the medium term continence of the two procedures. Subjective continence and patient satisfaction measures will be obtained at each of the above visits using standardized questionnaires and pelvic organ support will be quantified by Pelvic Organ Prolapse-Quantification (POP-Q) scores.
- Early events (e.g., blood loss, operative time, intra-operative complications (vascular, bowel and urological injuries), in-hospital complications (need for transfusion, febrile morbidity, thrombotic events, wound infection, length of stay, duration of bladder catheterization and ileus) and delayed postoperative complications (e.g., wound infection, mesh erosion, bowel obstruction and obstructed voiding) will be collected to compare the safety of each procedure.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Procedure: Burch urethropexy Procedure: Synthetic mid-urethral sling (TVT)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Comparison of Concomitant Incontinence Procedures Performed With Abdominal Sacral Colpopexy: the Burch Versus Mid-urethral Sling Trial|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Active Comparator: Burch
Patients will receive a Burch urethropexy at the time of an abdominal sacral colpopexy.
Procedure: Burch urethropexy
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).
Experimental: Mid-urethral sling
Patients will receive a mid-urethral sling at the time of an abdominal sacral colpopexy.
Procedure: Synthetic mid-urethral sling (TVT)
Patients will undergo a polypropylene mid urethral sling as described by the manufacture (Align, Bard Urological, Covington, GA).
Other Name: TVT
- 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) [ Time Frame: 6 months ]
- 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. [ Time Frame: 6 months ]
- To compared continence, stress specific continence and patient satisfaction between groups at 12 and 24 months. [ Time Frame: 12 and 24 months ]
- Compare the safety of the Burch and the mid-urethral sling. [ Time Frame: 6, 12 and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934999
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Emanuel C. Trabuco, MD, MS||Mayo Clinic|