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NCT05063331 · ClinicalTrials.gov registry record · NA
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
A NA study of Uterine Prolapse, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 320
- Enrollment target
- 7
- Study locations
NCT05063331: Recruiting NA study of Uterine Prolapse, sponsored by University Hospitals Cleveland Medical Center.
NCT05063331 is a NA study of Uterine Prolapse that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 320 participants, above the 150-participant average among 3 other Uterine Prolapse trials with a reported enrollment target (113% higher). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05063331, a NA study of Uterine Prolapse, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 320 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
The primary outcome is treatment failure defined as the presence of at least one of the following: 1) presence of a vaginal bulge defined as lead point of prolapse beyond the hymen, 2) report of bothersome vaginal bulge symptoms irrespective of stage of prolapse, or 3) retreatment of symptomatic prolapse with pessary, or surgery.
Conditions Studied
Interventions
- PROCEDURE Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)
- PROCEDURE Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Study Locations (7)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- MetroHealth Medical Center - Cleveland
- Cleveland Clinic - Cleveland
Florida
- Mayo Clinic - Jacksonville
Illinois
- Northwestern Medicine - Chicago
North Carolina
- Duke University - Durham
Pennsylvania
- University of Pittsburgh, UPMC Magee-Womens Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2021-12-15 |
| Est. Completion | 2030-07-31 |
| Phase | NA |
What NCT05063331 shows while recruiting
NCT05063331 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 150-participant average among 3 other Uterine Prolapse trials with a reported enrollment target (113% higher).
The record links to 1 condition, with Uterine Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) is the first listed.
NCT05063331 lists 7 locations in 5 states (Ohio, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT05063331 about?
NCT05063331 is a clinical study titled "Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse". 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.
What is the current status of trial NCT05063331?
This trial is currently recruiting. It is a NA study. The enrollment target is 320 participants. The study started on 2021-12-15. Estimated completion is 2030-07-31.
What conditions does trial NCT05063331 study?
This clinical trial studies the following conditions: Uterine Prolapse.
What interventions are being tested in trial NCT05063331?
The interventions under investigation include: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) (PROCEDURE), Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) (PROCEDURE).
Who is sponsoring clinical trial NCT05063331?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05063331 being conducted?
This trial has 7 study locations across Florida, Illinois, North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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