SORE Study: Sitz Baths After Urogynecologic Reconstruction (SORE)

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse; Postoperative Pain Management; Gynecologic Surgeries
• Intervention / Treatment: Device: Sitz Bath

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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Markowitz, MD; Phone Number: 203-909-5267; Email: melissa.markowitz@yale.edu
• Study Contact Backup: Name: Koray Gorkem Sacinti, MD, MPH; Email: koraygorkem.sacinti@yale.edu

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Recruiting
      • Bridgeport Hospital
    • Greenwich, Connecticut, United States, 06830
      • Recruiting
      • Greenwich Hospital
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale-New Haven Hospital
    • New London, Connecticut, United States, 06320
      • Recruiting
      • Lawrence + Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sitz baths plus usual care; Warm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives.	Device: Sitz Bath; Warm water sitz bath, 7 nights, 10 minutes each
No Intervention: Usual care; Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire	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.	Day 7 Post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Urogynecologic Society
• Investigators: Principal Investigator: Nancy Ringel, MD, MS, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 8, 2025
• First Submitted That Met QC Criteria: October 8, 2025
• First Posted (Estimated): October 14, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse surgical repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse
• Other Study ID Numbers: 2000040422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No