NCT07215780 SORE Study: Sitz Baths After Urogynecologic Reconstruction
| NCT ID | NCT07215780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Pelvic Organ Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2025-10-28 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Nancy Ringel, MD, MS
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07215780 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07215780 currently recruiting?
Yes, NCT07215780 is actively recruiting participants. Contact the research team at melissa.markowitz@yale.edu for enrollment information.
Where is the NCT07215780 trial being conducted?
This trial is being conducted at Bridgeport, United States, Greenwich, United States, New Haven, United States, New London, United States.
Who is sponsoring the NCT07215780 clinical trial?
NCT07215780 is sponsored by Yale University. The principal investigator is Nancy Ringel, MD, MS at Yale University. The trial plans to enroll 112 participants.