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SORE Study: Sitz Baths After Urogynecologic Reconstruction

ConditionsPelvic Organ ProlapsePostoperative Pain ManagementGynecologic Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sitz Bath

    Device

    Warm water sitz bath, 7 nights, 10 minutes each

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Sitz baths plus usual careExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Day 7 Post surgery

Secondary outcomes

1

Mean score patient satisfaction

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

Time frame
Day 7 Post surgery
2

Mean Oxycodone use

Mean number of oxycodone tablets used postoperatively

Time frame
Day 7 Post surgery
3

Comfort with postoperative pain plan

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

Time frame
Day 7 Post surgery
4

Comfort with postoperative pain plan using Sitz bath

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)

Time frame
Day 7 Post surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

American Urogynecologic Society

Collaborator

Source ClinicalTrials.gov
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