SORE Study: Sitz Baths After Urogynecologic Reconstruction

Yale University

Status

Enrolling

Conditions

Postoperative Pain Management

Gynecologic Surgeries

Pelvic Organ Prolapse

Treatments

Device: Sitz Bath

Study type

Interventional

Funder types

Other

Identifiers

NCT07215780

2000040422

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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