What is this study studying for pelvic organ prolapse?

This study is evaluating whether using sitz baths after pelvic organ prolapse surgery helps reduce pain and improve recovery. Researchers will compare pain levels one week after surgery between patients using sitz baths and those receiving usual care. The study is sponsored by Yale University and aims to inform better pain management after surgery.

Who may be eligible for this pelvic organ prolapse clinical trial?

Women aged 18 or older with documented Stage 2, 3, or 4 pelvic organ prolapse who are scheduled for surgery by a urogynecologist may be eligible. Participants must speak English or Spanish and not use daily opioids. Please review eligibility criteria for more details.

Is there any cost to participate in this pelvic organ prolapse clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses vary and may not be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

FEMALE

ID07215780

SORE Study Sitz Baths After Urogynecologic Reconstruction

Led by Yale University · Updated on 2025-12-03

112

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying women undergoing surgical repair of pelvic organ prolapse to evaluate how effective postoperative sitz baths are in managing pain and aiding recovery. This prospective, randomized controlled trial, called the SORE Study, compares the pain intensity reported one week after native tissue repair between patients using a sitz bath regimen and those receiving usual care. The study also aims to explore patient satisfaction with pain management, opioid use, healthcare visits, adherence to pain plans, and healing complications. Participants are assigned to one of two groups one group uses warm water sitz baths nightly for seven days after surgery along with usual care, while the other group receives usual care without sitz baths. The sitz bath involves soaking in warm water for 10 minutes each night. The study begins soon after surgery and includes a week of intervention and follow-up. Throughout the study, participants will complete questionnaires about their pain levels and satisfaction with pain management on day 7 after surgery. Researchers will track opioid use, adherence to the sitz bath regimen, any barriers to its use, rare adverse effects, and the number of calls or emergency visits related to pain up to 90 days after surgery. The total participation duration includes the initial week of treatment and monitoring up to 90 days for safety and healthcare use.

CONDITIONS

Brief Title

SORE Study: Sitz Baths After Urogynecologic Reconstruction

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Female 18 years of age or older at the time of surgery
English or Spanish-speaking
Documented pelvic organ prolapse Stage 2, 3, or 4 by POP-Q examination
Surgery performed by a urogynecologist
Ambulatory or inpatient surgery accepted

You will not qualify if you...

Mesh-augmented prolapse repair (robotic, laparoscopic, open sacrocolpopexy or sacrohysteropexy, vaginal mesh)
Urogynecologic surgery without prolapse repair (e.g., midurethral sling, intravesicular botox, hysterectomy only)
Suspected genital herpes, molluscum contagiosum, condyloma acuminata, or vulvar/vaginal skin infections at recruitment
Daily opioid use (short or long-acting)
Concurrent non-urogynecologic surgery (e.g., rectopexy, cancer staging or debulking)
Lack of access to operative report
Pregnant at the time of surgery
Incarcerated
Unable to give consent or have a legal guardian
Unable to complete study intervention or assessments as judged by investigators

Research Team

Melissa Markowitz, MD

Koray Gorkem Sacinti, MD, MPH

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