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SORE

Sitz Baths for Postoperative Pain After Urogynecologic Surgery

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Study AimThe study aims to evaluate if sitz baths can help reduce pain after urogynecologic surgery in women.
What is being tested

Sitz Bath

Device
Who is being recruted

Pelvic Organ Prolapse

+ Postoperative Pain Management
+ Gynecologic Surgeries
Over 18 Years
+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorYale University
Study ContactMelissa Markowitz, MD
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 28, 2025Actual date on which the first participant was enrolled.

This study focuses on helping women who have undergone surgery to repair pelvic organ prolapse, a condition where organs like the bladder or uterus slip out of place. The goal is to see if taking sitz baths, a type of warm, shallow bath that cleanses the perineum, can reduce pain better than the usual care a week after their surgery. This is important because finding effective ways to manage pain after such surgeries could improve recovery experiences and reduce reliance on pain medications like opioids. Participants in the study will either follow a regimen of sitz baths or continue with their usual care after surgery. The study will measure how much pain they feel one week post-operation. It will also look at how satisfied they are with their pain management, how much opioid medication they think they need, and how well their surgical incisions are healing. The study will also keep track of their use of healthcare services and how well they stick to the postoperative care plan. Understanding these factors can help improve recovery processes and enhance patient care after pelvic organ prolapse surgery.

Official TitleSORE Study: Sitz Baths After Urogynecologic Reconstruction 
Principal SponsorYale University
Study ContactMelissa Markowitz, MD
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
112 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pelvic Organ Prolapse
Postoperative Pain Management
Gynecologic Surgeries
Criteria
5 inclusion criteria required to participate
Surgery to be performed by a urogynecologist
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

Show More Criteria

10 exclusion criteria prevent from participating
Lack of access to operative report
Unable to complete study intervention or assessment per investigators
Unable to give consent/conserved
Incarcerated

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Warm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives.
Group II
No Intervention
Care as usual
Study Objectives
Primary Objectives

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 Objectives

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

Mean number of oxycodone tablets used postoperatively

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

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)

Total use of sitz baths in minutes

Number of barriers to use perceived by self-report

Number of participants with any rare adverse effects per protocol

Mean number of requests for opioid refills postoperatively

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Recruiting
Bridgeport HospitalBridgeport, United StatesSee the location
Recruiting
Greenwich HospitalGreenwich, United States
Recruiting
Yale-New Haven HospitalNew Haven, United States
Recruiting
Lawrence + Memorial HospitalNew London, United States
Recruiting
4 Study Centers