REDUCE Trial- Reducing Prolapse Recurrence
Study Details
Study Description
Brief Summary
This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The decision to perform a posterior colpoperineorrhaphy at the time of sacrocolpopexy is controversial. Based on cohort data, some surgeons advocate that sacrocolpopexy alone is effective at treating posterior vaginal wall prolapse and the addition of posterior colpoperineorrhaphy only increases the likelihood of pain with defecation and dyspareunia. Experts theorize that placement of posterior vaginal mesh down to the perineal body provides adequate posterior support and reduces genital hiatus size. Others argue that placement of mesh too low on the posterior vagina may be associated with increased mesh exposure and pain secondary to mesh stiffness. No randomized trials exist comparing prolapse outcomes using new, ultra-light polypropylene mesh with and without posterior colpoperineorrhaphy. The investigators hypothesize that there will be no difference in prolapse outcomes after sacrocolpopexy using Restorelle mesh with and without posterior colpoperineorrhaphy. However, patients with a posterior colpoperineorrhaphy will be more likely to report pain with defecation and dyspareunia. This will be the first multicenter randomized trial comparing outcomes of sacrocolpopexy with and without posterior colpoperineorrhaphy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sacralcolpopexy with posterior colpoperineorrhaphy
|
Procedure: Posterior colpoperineorrhaphy
Patients having a sacralcolpopexy will be randomized to ultra lightweight mesh (Coloplast Restorelle) with posterior colpoperineorrhaphy or the same procedure without the posterior colpoperineorrhaphy
|
| No Intervention: Sacralcolpopexy without posterior colpoperineorrhaphy
|
Outcome Measures
Primary Outcome Measures
- Pelvic Organ Prolapse Quantification (POP-Q) System [1 Year]
The POP-Q System will be used to compare the rate of prolapse recurrence at 1 year between women undergoing a sacrocolpopexy with Restorelle mesh with and without a concomitant posterior colpoperineorrhaphy.
Secondary Outcome Measures
- Defecatory Dysfunction [1 Year]
To compare the rates of defecatory dysfunction using the Bristol Stool Scale (stool types measured from type 1-type 7) and the Colorectal-Anal Distress Inventory 8 (measured from 0-100 points).
- Dyspareunia [1 Year]
To compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)
- Surgical and Perioperative Events: Blood Loss [2 Weeks]
To compare the estimated blood loss (in milliliters) between groups.
- Surgical and Perioperative Events: Operative Time [Day of surgery]
To compare the operative time (in minutes as listed on the surgical case tracking) between groups.
- Surgical and Perioperative Events: Postoperative Pain [2 Weeks]
To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.
- Surgical and Perioperative Events: Pain Medication Use [2 Weeks]
To compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women over the age of 18
-
English or Spanish speaking
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Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh
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Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm
Exclusion Criteria:
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Patient has had prior prolapse surgery
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Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis)
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Baseline dyspareunia (patient reports that they have pain with vaginal intercourse when asked as a yes/no)
-
Patients with a score of 7 or greater in any one muscle on the Meister Pelvic Floor Exam
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Patient planning a concomitant Burch procedure
-
Pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
- University of Kansas
Investigators
- Principal Investigator: Julia Geynisman-Tan, M.D, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00214588