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NCT07215780NARecruiting

SORE Study: Sitz Baths After Urogynecologic Reconstruction

Yale University

Start Date

10/28/2025

Completion Date

6/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Sitz Bath

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Conditions

Pelvic Organ ProlapsePostoperative Pain ManagementGynecologic Surgeries

Locations

Bridgeport Hospital

Bridgeport, Connecticut 06610

United States

Greenwich Hospital

Greenwich, Connecticut 06830

United States

Yale-New Haven Hospital

New Haven, Connecticut 06520

United States

Lawrence + Memorial Hospital

New London, Connecticut 06320

United States