SORE Study: Sitz Baths After Urogynecologic Reconstruction

Part of paid clinical trials in Bridgeport, Connecticut.

Sponsor
Yale University
Study ID
NCT07215780
Status
Recruiting
Apply to this trial

Conditions

  • Gynecologic Surgeries
  • Pelvic Organ Prolapse
  • Postoperative Pain Management

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sitz Bath — DEVICE
    Warm water sitz bath, 7 nights, 10 minutes each

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire [ Time Frame: Day 7 Post surgery ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Bridgeport HospitalBridgeportConnecticut06610-
Greenwich HospitalGreenwichConnecticut06830-
Yale-New Haven HospitalNew HavenConnecticut06520-
Lawrence + Memorial HospitalNew LondonConnecticut06320-

Find similar trials in Bridgeport, CT

By research site
Bridgeport Hospital· Bridgeport, CTGreenwich Hospital· Greenwich, CTYale-New Haven Hospital· New Haven, CTLawrence + Memorial Hospital· New London, CT

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