NCT07215780

SORE Study: Sitz Baths After Urogynecologic Reconstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Organ Prolapse
• Postoperative Pain Management
• Gynecologic Surgeries

Interventions

Type	Name	Description
DEVICE	Sitz Bath	Warm water sitz bath, 7 nights, 10 minutes each

Timeline

• Start date: 2025-10-28
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2025-10-14
• Last updated: 2025-12-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study