SORE Study: Sitz Baths After Urogynecologic Reconstruction

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse; Postoperative Pain Management; Gynecologic Surgeries

• Registration Number: NCT07215780
• Lead Sponsor: Yale University

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, 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.

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 care.

The secondary objectives of this study are to evaluate patient satisfaction with pain management after native tissue prolapse repair (and specifically posterior repair and/or perineorrhaphy), patient-reported opioid requirements, healthcare utilization, postoperative pain plan adherence, and incisional healing and complications between those undergoing a sitz bath regimen versus usual care.

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-08
• Study First Submitted QC: 2025-10-08
• Study First Posted: 2025-10-14
• Last Update Submitted: 2025-10-15
• Last Update Posted: 2025-10-20
• Primary Completion: 2027-03
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

• Female ≥ 18 years of age at time of surgery
• English-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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire	Day 7 Post surgery	Pain intensity will be assessed on a 15-point scale evaluating current, worst, and average pain on postoperative day 7 following prolapse repair and converted to a T- score using general population data. Higher scores indicate increased pain intensity.

Secondary Outcome Measures

Name	Time	Method
Mean score patient satisfaction	Day 7 Post surgery	Satisfaction with postoperative pain management on a 0-100 mm visual analog scale
Mean Oxycodone use	Day 7 Post surgery	Mean number of oxycodone tablets used postoperatively
Comfort with postoperative pain plan	Day 7 Post surgery	Participant comfort level with managing postoperative multimodal pain plan on a 5-point Likert scale (1 = very uncomfortable, 5 = very comfortable)
Comfort with postoperative pain plan using Sitz bath	Day 7 Post surgery	Participant comfort with sitz bath setup and cleanup, accessibility to bathroom use, physical comfort during and after use of sitz bath on a 5-point Likert scale (1 = very uncomfortable, 5 = very comfortable)
Sitz bath use- Adherence	Day 7 Post surgery	Total use of sitz baths in minutes
Barriers to use- Adherence	Day 7 Post surgery	Number of barriers to use perceived by self-report
Number of participants with rare adverse effects	Day 7 Post surgery	Number of participants with any rare adverse effects per protocol
Mean Opioid use	Day 7 Post surgery	Mean number of requests for opioid refills postoperatively
Mean number of calls regarding pain	Up to Day 90 Post surgery	Mean number of calls or messages for postoperative pain within 90 days of surgery via review of medical record
Mean number of Emergency Department visits	Up to Day 90 Post surgery	Mean number of emergency department visits within 90 days of surgery via review of medical record

Trial Locations

Locations (4)

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Greenwich Hospital; 🇺🇸 Greenwich, Connecticut, United States

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Lawrence + Memorial Hospital; 🇺🇸 New London, Connecticut, United States