SORE Study: Sitz Baths After Urogynecologic Reconstruction
Recruiting now · Not applicable
Conditions studied: Pelvic Organ Prolapse, Postoperative Pain Management, Gynecologic Surgeries
In brief
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.
Key facts
- Study ID
- NCT07215780
- Run by
- Yale University
- People needed
- 112
- Starts
- 2025-10-28
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-12-03
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Bridgeport Hospital — Bridgeport, Connecticut, United States (enrolling)
- Greenwich Hospital — Greenwich, Connecticut, United States (enrolling)
- Yale-New Haven Hospital — New Haven, Connecticut, United States (enrolling)
- Lawrence + Memorial Hospital — New London, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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