Actively Recruiting
SORE Study: Sitz Baths After Urogynecologic Reconstruction
Led by Yale University · Updated on 2025-12-03
112
Participants Needed
4
Research Sites
83 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
A
American Urogynecologic Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SORE Study: Sitz Baths After Urogynecologic Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female 18 years of age or older at time of surgery
- English or Spanish-speaking
- Documented pelvic organ prolapse Stage 2, 3, or 4 on preoperative exam
- Surgery performed by a urogynecologist
- Ambulatory or inpatient surgery accepted
You will not qualify if you...
- Mesh-augmented prolapse repair surgery
- Urogynecologic surgery without prolapse repair (e.g., midurethral sling, intravesicular botox, hysterectomy only)
- Suspected genital herpes, molluscum contagiosum, condyloma acuminata, or vulvar/vaginal skin or soft tissue infection
- Daily use of opioids (short or long-acting)
- Concurrent non-urogynecologic surgery (e.g., rectopexy, cancer staging or debulking)
- No access to operative report
- Pregnant as confirmed by urine pregnancy test or medical documentation
- Incarcerated individuals
- Unable to give consent or are conserved
- Unable to complete study intervention or assessments as determined by investigators
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Actively Recruiting
2
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Actively Recruiting
3
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
Lawrence + Memorial Hospital
New London, Connecticut, United States, 06320
Actively Recruiting
Research Team
M
Melissa Markowitz, MD
CONTACT
K
Koray Gorkem Sacinti, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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