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SORE Study: Sitz Baths After Urogynecologic Reconstruction

NCT07215780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-12-03

No results posted yet for this study

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
  • Postoperative Pain Management
  • Gynecologic Surgeries

Interventions

DEVICE

Sitz Bath

Warm water sitz bath, 7 nights, 10 minutes each

Sponsors & Collaborators

  • American Urogynecologic Society

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Nancy Ringel, MD, MS · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215780 on ClinicalTrials.gov