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NCT07215780 · ClinicalTrials.gov registry record · NA
SORE Study: Sitz Baths After Urogynecologic Reconstruction
A NA study of Pelvic Organ Prolapse and Postoperative Pain Management, sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 112
- Enrollment target
- 4
- Study locations
NCT07215780: Recruiting NA study of Pelvic Organ Prolapse and Postoperative Pain Management, sponsored by Yale University.
NCT07215780 is a NA study of Pelvic Organ Prolapse and Postoperative Pain Management that is actively recruiting participants, run by Yale University. The registered enrollment target is 112 participants, below the 142-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (21% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215780, a NA study of Pelvic Organ Prolapse and Postoperative Pain Management, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to evaluate the utility of postoperative sitz baths in patient pain perception and recovery following surgical repair of prolapse. The SORE Study is a prospective, randomized controlled trial that aims to compare postoperative pain intensity one week after native tissue repair of pelvic organ prolapse for patients undergoing a sitz bath regimen versus usual care. Findings from this study may contribute to more robust, multimodal postoperative pain management plans if proven efficacious or, alternatively, reduce plastic medical waste and simplify postoperative pain plans if found to be ineffective.
Primary Outcome
Pain intensity will be assessed on a 15-point scale evaluating current, worst, and average pain on postoperative day 7 following prolapse repair and converted to a T- score using general population data. Higher scores indicate increased pain intensity.
Conditions Studied
Interventions
- DEVICE Sitz Bath
Study Locations (4)
Connecticut
- Bridgeport Hospital - Bridgeport
- Greenwich Hospital - Greenwich
- Yale-New Haven Hospital - New Haven
- Lawrence + Memorial Hospital - New London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2025-10-28 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT07215780 shows while recruiting
NCT07215780 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (21% lower).
The record links to 3 conditions, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 1 intervention - of which Sitz Bath is the first listed.
NCT07215780 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT07215780 about?
NCT07215780 is a clinical study titled "SORE Study: Sitz Baths After Urogynecologic Reconstruction". The purpose of this study is to evaluate the utility of postoperative sitz baths in patient pain perception and recovery following surgical repair of prolapse. The SORE Study is a prospective, randomized controlled trial that aims to compare postoperative pain intensity one week after native tissue ...
What is the current status of trial NCT07215780?
This trial is currently recruiting. It is a NA study. The enrollment target is 112 participants. The study started on 2025-10-28. Estimated completion is 2027-06.
What conditions does trial NCT07215780 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse, Postoperative Pain Management, Gynecologic Surgeries.
What interventions are being tested in trial NCT07215780?
The interventions under investigation include: Sitz Bath (DEVICE).
Who is sponsoring clinical trial NCT07215780?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07215780 being conducted?
This trial has 4 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pelvic Organ Prolapse
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07215780's enrollment target sits among peer trials
112 15th of 40 higher than 25 of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Organ Prolapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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