Clinical trial NCT04880239: REDUCE Trial- Reducing Prolapse Recurrence
Official title: REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolapse; Female
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
name: University of Kansas
First posted: 2021-05-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.

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.

Eligibility criteria: Inclusion Criteria:

* Women over the age of 18
* English or Spanish speaking
* Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh
* Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm

Exclusion Criteria:

* Patient has had prior prolapse surgery
* Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis)
* 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
* Patient planning a concomitant Burch procedure
* Pregnant

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification (POP-Q) System
timeFrame: 1 Year
Secondary outcomes:
measure: Defecatory Dysfunction
timeFrame: 1 Year
measure: Dyspareunia
timeFrame: 1 Year
measure: Surgical and Perioperative Events: Blood Loss
timeFrame: 2 Weeks
measure: Surgical and Perioperative Events: Operative Time
timeFrame: Day of surgery
measure: Surgical and Perioperative Events: Postoperative Pain
timeFrame: 2 Weeks
measure: Surgical and Perioperative Events: Pain Medication Use
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Julia Geynisman-Tan, M.D
role: PRINCIPAL_INVESTIGATOR
References: