About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Sitz Bath
Treatment groups
Sponsors and collaborators
Yale University
Lead sponsor
American Urogynecologic Society
Collaborator