SORE Study: Sitz Baths After Urogynecologic Reconstruction

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Bridgeport Hospital
RECRUITING
Bridgeport
Greenwich Hospital
RECRUITING
Greenwich
Yale-New Haven Hospital
RECRUITING
New Haven
Lawrence + Memorial Hospital
RECRUITING
New London
Contact Information
Primary
Melissa Markowitz, MD
melissa.markowitz@yale.edu
203-909-5267
Backup
Koray Gorkem Sacinti, MD, MPH
koraygorkem.sacinti@yale.edu
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2027-06
Participants
Target number of participants: 112
Treatments
Experimental: Sitz baths plus usual care
Warm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives.
No_intervention: Usual care
Care as usual
Related Therapeutic Areas
Sponsors
Collaborators: American Urogynecologic Society
Leads: Yale University

This content was sourced from clinicaltrials.gov