Sitz baths after pelvic organ prolapse repair
SORE Study: Sitz Baths After Urogynecologic Reconstruction
This randomized trial will test whether regular sitz baths after native tissue pelvic organ prolapse repair reduce pain and improve recovery for adult women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 4 sites (Bridgeport, Connecticut and 3 other locations) |
| Trial ID | NCT07215780 on ClinicalTrials.gov |
What this trial studies
The SORE study is a prospective, randomized controlled trial comparing a postoperative sitz bath regimen to usual care after native tissue repair of pelvic organ prolapse. The primary outcome is patient-reported pain intensity one week after surgery. Secondary outcomes include patient satisfaction with pain management, opioid use, healthcare utilization, adherence to the pain plan, and incisional healing or complications. The trial is being conducted at multiple Yale-affiliated hospitals and enrolls adult English- or Spanish-speaking women with POP-Q stage 2–4 undergoing urogynecologic repair (excluding mesh-augmented repairs).
Who should consider this trial
Good fit: Adult women (≥18) who speak English or Spanish and are having native tissue pelvic organ prolapse repair (POP-Q stage 2–4) performed by a urogynecologist at a participating site are ideal candidates.
Not a fit: Patients undergoing mesh-augmented repairs, daily opioid users, those with active genital infections, concurrent non-urogynecologic surgery, or lacking access to the operative report are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If effective, sitz baths could reduce short-term postoperative pain, lower opioid requirements, and simplify recovery instructions.
How similar studies have performed: Sitz baths are widely used after perineal procedures, but high-quality randomized evidence specifically for prolapse repair is limited and results are inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Bridgeport, Connecticut and 3 other locations
- Bridgeport Hospital — Bridgeport, Connecticut, United States (Recruiting)
- Greenwich Hospital — Greenwich, Connecticut, United States (Recruiting)
- Yale-New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Lawrence + Memorial Hospital — New London, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Nancy Ringel, MD, MS — Yale University
- Study coordinator: Melissa Markowitz, MD
- Email: melissa.markowitz@yale.edu
- Phone: 203-909-5267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.