RECRUITING

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

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Conditions

Uterine ProlapseSacrocolpopexyUterosacral Ligament Suspension

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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

The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.

Official Title

Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse

Quick Facts

Study Start:2021-12-15
Study Completion:2030-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05063331

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 to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women ≥ 18 years of age and ≤ 80 years of age
  2. 2. Have diagnosis of symptomatic uterovaginal prolapse
  3. 3. Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
  4. 4. Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
  1. 1. Patients who wish to undergo uterine sparing procedures
  2. 2. Body mass index BMI) \> 50
  3. 3. Previous hysterectomy or prior uterovaginal surgery
  4. 4. Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
  5. 5. Chronic indwelling urinary catheter
  6. 6. Urinary diversion of any type
  7. 7. Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
  8. 8. Unable to speak, read, understand English

Contacts and Locations

Study Contact

Sarah Wido
CONTACT
216-844-2183
Sarah.Wido@uhhospitals.org
Ellen Divoky
CONTACT
216-844-8092
Ellen.Divoky@uhhospitals.org

Principal Investigator

Adonis Hijaz, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

Mayo Clinic
Jacksonville, Florida, 32224
United States
Duke University
Durham, North Carolina, 27707
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Pittsburgh, UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • Adonis Hijaz, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

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 Date2021-12-15
Study Completion Date2030-07-31

Study Record Updates

Study Start Date2021-12-15
Study Completion Date2030-07-31

Terms related to this study

Keywords Provided by Researchers

  • Sacrocolpopexy
  • Uterosacral Ligament Suspension

Additional Relevant MeSH Terms

  • Uterine Prolapse