SORE Study: Sitz Baths After Urogynecologic Reconstruction
Yale University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- 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 on…
Interventions
- DeviceSitz Bath
Warm water sitz bath, 7 nights, 10 minutes each
Locations (4)
- Bridgeport HospitalBridgeport, Connecticut
- Greenwich HospitalGreenwich, Connecticut
- Yale-New Haven HospitalNew Haven, Connecticut
- Lawrence + Memorial HospitalNew London, Connecticut