Reducing recurrence of prolapse after surgery
REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
This study is testing if adding an extra surgical procedure to a common prolapse repair can help women avoid having their prolapse come back and reduce complications like pain during bowel movements and sex.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04880239 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether adding a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair improves outcomes for women with symptomatic prolapse. The study aims to compare the effectiveness of sacrocolpopexy alone versus sacrocolpopexy with the additional procedure, focusing on the rates of prolapse recurrence and associated complications such as pain during defecation and dyspareunia. It is the first multicenter randomized trial to evaluate these outcomes using new ultra-light polypropylene mesh. Participants will be women over 18 years old who are symptomatic and meet specific criteria.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with symptomatic prolapse (stage II or greater) who are undergoing minimally-invasive sacrocolpopexy.
Not a fit: Patients who have had prior prolapse surgery or those with inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques for treating prolapse, potentially reducing recurrence rates and associated complications.
How similar studies have performed: This approach is novel as no randomized trials have previously compared these specific surgical outcomes using ultra-light polypropylene mesh.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Julia Geynisman-Tan, M.D — Northwestern University
- Study coordinator: Julia Geynisman-Tan, MD
- Email: julia.geynisman-tan@nm.org
- Phone: 16302478274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.