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REDUCE Trial- Reducing Prolapse Recurrence

Primary Purpose

Prolapse; Female

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posterior colpoperineorrhaphy
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolapse; Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sacralcolpopexy with posterior colpoperineorrhaphy

Sacralcolpopexy without posterior colpoperineorrhaphy

Arm Description

Outcomes

Primary Outcome Measures

Pelvic Organ Prolapse Quantification (POP-Q) System
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
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
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
To compare the estimated blood loss (in milliliters) between groups.
Surgical and Perioperative Events: Operative Time
To compare the operative time (in minutes as listed on the surgical case tracking) between groups.
Surgical and Perioperative Events: Postoperative Pain
To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.
Surgical and Perioperative Events: Pain Medication Use
To compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.

Full Information

First Posted
April 14, 2021
Last Updated
January 26, 2023
Sponsor
Northwestern University
Collaborators
The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania, University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT04880239
Brief Title
REDUCE Trial- Reducing Prolapse Recurrence
Official Title
REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania, University of Kansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse; Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sacralcolpopexy with posterior colpoperineorrhaphy
Arm Type
Active Comparator
Arm Title
Sacralcolpopexy without posterior colpoperineorrhaphy
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Posterior colpoperineorrhaphy
Intervention Description
Patients having a sacralcolpopexy will be randomized to ultra lightweight mesh (Coloplast Restorelle) with posterior colpoperineorrhaphy or the same procedure without the posterior colpoperineorrhaphy
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification (POP-Q) System
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Defecatory Dysfunction
Description
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).
Time Frame
1 Year
Title
Dyspareunia
Description
To compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)
Time Frame
1 Year
Title
Surgical and Perioperative Events: Blood Loss
Description
To compare the estimated blood loss (in milliliters) between groups.
Time Frame
2 Weeks
Title
Surgical and Perioperative Events: Operative Time
Description
To compare the operative time (in minutes as listed on the surgical case tracking) between groups.
Time Frame
Day of surgery
Title
Surgical and Perioperative Events: Postoperative Pain
Description
To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.
Time Frame
2 Weeks
Title
Surgical and Perioperative Events: Pain Medication Use
Description
To compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.
Time Frame
2 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Villegas, BS/MA
Phone
312-503.1447
Email
andrea.villegas@nm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Geynisman-Tan, M.D
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylwia Clarke, BA
Phone
312-695-7748
Email
sylwia.clarke@nm.org

12. IPD Sharing Statement

Plan to Share IPD
No

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REDUCE Trial- Reducing Prolapse Recurrence

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