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NCT Number: NCT07215780

SORE Study: Sitz Baths After Urogynecologic Reconstruction

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bridgeport Hospital, Bridgeport, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitz Bath

Device

Warm water sitz bath, 7 nights, 10 minutes each

Primary outcomes

  1. Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire

    Time frame: Day 7 Post surgery

    Pain intensity will be assessed on a 15-point scale evaluating current, worst, and average pain on postoperative day 7 following prolapse repair and converted to a T- score using general population data. Higher scores indicate increased pain intensity.

Secondary outcomes

  1. Mean score patient satisfaction

    Time frame: Day 7 Post surgery

    Satisfaction with postoperative pain management on a 0-100 mm visual analog scale

  2. Mean Oxycodone use

    Time frame: Day 7 Post surgery

    Mean number of oxycodone tablets used postoperatively

  3. Comfort with postoperative pain plan

    Time frame: Day 7 Post surgery

    Participant comfort level with managing postoperative multimodal pain plan on a 5-point Likert scale (1 = very uncomfortable, 5 = very comfortable)

  4. Comfort with postoperative pain plan using Sitz bath

    Time frame: Day 7 Post surgery

    Participant comfort with sitz bath setup and cleanup, accessibility to bathroom use, physical comfort during and after use of sitz bath on a 5-point Likert scale (1 = very uncomfortable, 5 = very comfortable)

  5. Sitz bath use- Adherence

    Time frame: Day 7 Post surgery

    Total use of sitz baths in minutes

  6. Barriers to use- Adherence

    Time frame: Day 7 Post surgery

    Number of barriers to use perceived by self-report

  7. Number of participants with rare adverse effects

    Time frame: Day 7 Post surgery

    Number of participants with any rare adverse effects per protocol

  8. Mean Opioid use

    Time frame: Day 7 Post surgery

    Mean number of requests for opioid refills postoperatively

  9. Mean number of calls regarding pain

    Time frame: Up to Day 90 Post surgery

    Mean number of calls or messages for postoperative pain within 90 days of surgery via review of medical record

  10. Mean number of Emergency Department visits

    Time frame: Up to Day 90 Post surgery

    Mean number of emergency department visits within 90 days of surgery via review of medical record

Study contacts

Contact information is provided by the study sponsor or research team.

Koray Gorkem Sacinti, MD, MPH

CONTACT

[email protected]

Melissa Markowitz, MD

CONTACT

[email protected]

203-909-5267

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Urogynecologic Society

Registry information

Acronym: SORE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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