Comparison of Burch Urethropexy and Mid-urethral Sling Performed Concomitantly With a Sacral Colpopexy
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2009 |
| End Date: | October 2015 |
A Randomized Comparison of Concomitant Incontinence Procedures Performed With Abdominal Sacral Colpopexy: the Burch Versus Mid-urethral Sling Trial
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:
1. 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.
2. 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.
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:
1. 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.
2. 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.
Inclusion Criteria:
1. older than 21 years of age;
2. with symptomatic pelvic organ prolapse (POP-Q point Aa or C at ≥ -1 cm;
3. who have opted for sacral colpopexy repair of prolapse;
4. who have symptomatic SUI desiring surgical correction or who have occult SUI;
5. who have urethral hypermobility;
6. with a maximal cystometric capacity ≥ 200 cc;
7. who are willing to return for follow-up visit; or
8. who understand and have signed written informed consent to undergo randomization and
who has given investigators permission to collect data pertaining to surgical care
and follow-up.
Exclusion Criteria:
1. with known or suspected disease that affect bladder function (i.e., multiple
sclerosis, Parkinson's Disease, spinal cord injury, etc.);
2. who are pregnant by self report or by positive pregnancy test;
3. who desire to maintain fertility;
4. with history of urethral diverticulum;
5. with a history of radical pelvic surgery or pelvic radiation therapy;
6. who are deemed medically poor candidates for abdominal surgery;
7. Non-ambulatory (including those who ambulate with assistance; or
8. who are actively undergoing chemotherapy or radiation treatment for malignancy.
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