Sitz Bath
DeviceWarm water sitz bath, 7 nights, 10 minutes each
NCT Number: NCT07215780
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Bridgeport Hospital, Bridgeport, Connecticut, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Warm water sitz bath, 7 nights, 10 minutes each
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.
Time frame: Day 7 Post surgery
Satisfaction with postoperative pain management on a 0-100 mm visual analog scale
Time frame: Day 7 Post surgery
Mean number of oxycodone tablets used postoperatively
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)
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)
Time frame: Day 7 Post surgery
Total use of sitz baths in minutes
Time frame: Day 7 Post surgery
Number of barriers to use perceived by self-report
Time frame: Day 7 Post surgery
Number of participants with any rare adverse effects per protocol
Time frame: Day 7 Post surgery
Mean number of requests for opioid refills postoperatively
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
Time frame: Up to Day 90 Post surgery
Mean number of emergency department visits within 90 days of surgery via review of medical record
Contact information is provided by the study sponsor or research team.
Koray Gorkem Sacinti, MD, MPH
CONTACT
Melissa Markowitz, MD
CONTACT
Yale University
Other
Acronym: SORE
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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