RECRUITING

REDUCE Trial- Reducing Prolapse Recurrence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus

Quick Facts

Study Start:2021-11-23
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04880239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women over the age of 18
  2. * English or Spanish speaking
  3. * Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh
  4. * Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm
  1. * Patient has had prior prolapse surgery
  2. * Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis)
  3. * Baseline dyspareunia (patient reports that they have pain with vaginal intercourse when asked as a yes/no)
  4. * Patients with a score of 7 or greater in any one muscle on the Meister Pelvic Floor Exam
  5. * Patient planning a concomitant Burch procedure
  6. * Pregnant

Contacts and Locations

Study Contact

Julia Geynisman-Tan, MD
CONTACT
16302478274
julia.geynisman-tan@nm.org

Principal Investigator

Julia Geynisman-Tan, M.D
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Julia Geynisman-Tan, M.D, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-23
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2021-11-23
Study Completion Date2026-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Prolapse; Female