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Recruiting NCT07215780

SORE Study: Sitz Baths After Urogynecologic Reconstruction

No phase Interventional Pelvic Organ Prolapse Postoperative Pain Management Gynecologic Surgeries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sitz Bath.
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse, Postoperative Pain Management, Gynecologic Surgeries. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Device Sitz Bath
    Warm water sitz bath, 7 nights, 10 minutes each

Primary outcome measures

  • Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire [Time frame: Day 7 Post surgery]
Secondary outcome measures (10)
  • Mean score patient satisfaction [Time frame: Day 7 Post surgery]
  • Mean Oxycodone use [Time frame: Day 7 Post surgery]
  • Comfort with postoperative pain plan [Time frame: Day 7 Post surgery]
  • Comfort with postoperative pain plan using Sitz bath [Time frame: Day 7 Post surgery]
  • Sitz bath use- Adherence [Time frame: Day 7 Post surgery]
  • Barriers to use- Adherence [Time frame: Day 7 Post surgery]
  • Number of participants with rare adverse effects [Time frame: Day 7 Post surgery]
  • Mean Opioid use [Time frame: Day 7 Post surgery]
  • Mean number of calls regarding pain [Time frame: Up to Day 90 Post surgery]
  • Mean number of Emergency Department visits [Time frame: Up to Day 90 Post surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 4 centers
  • Bridgeport Hospital — Bridgeport
  • Greenwich Hospital — Greenwich
  • Yale-New Haven Hospital — New Haven
  • Lawrence + Memorial Hospital — New London

Identifiers

NCT: NCT07215780 · 2000040422

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗