Status:
RECRUITING
SORE Study: Sitz Baths After Urogynecologic Reconstruction
Lead Sponsor:
Yale University
Collaborating Sponsors:
American Urogynecologic Society
Conditions:
Pelvic Organ Prolapse
Postoperative Pain Management
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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, randomi...
Detailed Description
The primary objective of the SORE study is to compare postoperative pain intensity one week after native tissue repair of pelvic organ prolapse for patients undergoing a sitz bath regimen versus usual...
Eligibility Criteria
Inclusion
- Female ≥ 18 years of age at time of surgery
- English or Spanish-speaking
- Documentation of pelvic organ prolapse as evidenced by Stage 2, 3, or 4 prolapse on preoperative Pelvic Organ Prolapse Quantification system (POP-Q) examination
- Surgery to be performed by a urogynecologist
- Ambulatory or inpatient surgery acceptable
Exclusion
- Mesh-augmented prolapse repair (robotic, laparoscopic, or open sacrocolpopexy or sacrohysteropexy, vaginal mesh)
- Urogynecologic surgery without prolapse repair (i.e. midurethral sling, intravesicular botox, hysterectomy only)
- Suspected genital herpes simplex virus (HSV), molluscum contagiosum virus (MCV), condyloma acuminata, or vulvar/vaginal skin and soft tissue infection at recruitment by patient report
- Daily opioid use (short or long-acting)
- Concurrent non-urogynecologic surgery (i.e. rectopexy, staging or debulking for malignancy)
- Lack of access to operative report
- Pregnant (as determined by positive urine pregnancy test on the day of surgery via standard testing or current pregnancy documented in the preoperative note)
- Incarcerated
- Unable to give consent/conserved
- Unable to complete study intervention or assessment per investigators
Key Trial Info
Start Date :
October 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT07215780
Start Date
October 28 2025
End Date
June 1 2027
Last Update
December 3 2025
Active Locations (4)
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1
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
2
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
3
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
4
Lawrence + Memorial Hospital
New London, Connecticut, United States, 06320