SORE Study: Sitz Baths After Urogynecologic Reconstruction
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The study population will consist of adult patients undergoing native tissue surgical repair of pelvic organ prolapse at a Yale-affiliated hospital.
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Bridgeport 5282804, Connecticut 4831725 06610
Greenwich 4835395, Connecticut 4831725 06830
New Haven 4839366, Connecticut 4831725 06520
New London 4839416, Connecticut 4831725 06320
More Details
- NCT ID
- NCT07215780
- Status
- Recruiting
- Sponsor
- Yale University
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.