SORE Study: Sitz Baths After Urogynecologic Reconstruction

NCT07215780 | Recruiting FDA Device

• 1 other identifier: 2000040422
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 4

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.

Conditions

Pelvic Organ Prolapse; Gynecologic Surgeries; Postoperative Pain Management

Keywords

Pelvic organ prolapse surgical repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mean score patient satisfaction

  Day 7 Post surgery

• Mean Oxycodone use

  Day 7 Post surgery

• Comfort with postoperative pain plan

  Day 7 Post surgery

• Comfort with postoperative pain plan using Sitz bath

  Day 7 Post surgery

• Sitz bath use- Adherence

  Day 7 Post surgery

Study Arms (2)

Sitz baths plus usual care

EXPERIMENTAL

Warm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives.

Device: Sitz Bath

Usual care

NO INTERVENTION

Care as usual

Interventions

Sitz Bath DEVICE

Warm water sitz bath, 7 nights, 10 minutes each

Sitz baths plus usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yale University: lead
• American Urogynecologic Society: collaborator

Study Sites (4)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

RECRUITING

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

RECRUITING

Yale-New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

Lawrence + Memorial Hospital

New London, Connecticut, 06320, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy Ringel, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Markowitz, MD

CONTACT

203-909-5267; melissa.markowitz@yale.edu

Koray Gorkem Sacinti, MD, MPH

CONTACT

koraygorkem.sacinti@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study population will consist of adult patients undergoing native tissue surgical repair of pelvic organ prolapse at a Yale-affiliated hospital.

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 14, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)