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| Name | Class |
|---|---|
| American Urogynecologic Society | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitz baths plus usual care | Experimental | Warm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives. |
|
| Usual care | No Intervention | Care as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitz Bath | Device | Warm water sitz bath, 7 nights, 10 minutes each |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 Post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean score patient satisfaction | Satisfaction with postoperative pain management on a 0-100 mm visual analog scale | Day 7 Post surgery |
| Mean Oxycodone use | Mean number of oxycodone tablets used postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Markowitz, MD | Contact | 203-909-5267 | melissa.markowitz@yale.edu | |
| Koray Gorkem Sacinti, MD, MPH | Contact | koraygorkem.sacinti@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nancy Ringel, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Recruiting | Bridgeport | Connecticut | 06610 | United States | |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study population will consist of adult patients undergoing native tissue surgical repair of pelvic organ prolapse at a Yale-affiliated hospital.
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| Day 7 Post surgery |
| 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) | Day 7 Post surgery |
| 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) | Day 7 Post surgery |
| Sitz bath use- Adherence | Total use of sitz baths in minutes | Day 7 Post surgery |
| Barriers to use- Adherence | Number of barriers to use perceived by self-report | Day 7 Post surgery |
| Number of participants with rare adverse effects | Number of participants with any rare adverse effects per protocol | Day 7 Post surgery |
| Mean Opioid use | Mean number of requests for opioid refills postoperatively | Day 7 Post surgery |
| Mean number of calls regarding pain | Mean number of calls or messages for postoperative pain within 90 days of surgery via review of medical record | Up to Day 90 Post surgery |
| Mean number of Emergency Department visits | Mean number of emergency department visits within 90 days of surgery via review of medical record | Up to Day 90 Post surgery |
| Greenwich Hospital |
| Recruiting |
| Greenwich |
| Connecticut |
| 06830 |
| United States |
| Yale-New Haven Hospital | Recruiting | New Haven | Connecticut | 06520 | United States |
| Lawrence + Memorial Hospital | Recruiting | New London | Connecticut | 06320 | United States |