Recruiting

SORESitz Baths for Postoperative Pain After Urogynecologic Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

The 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

Prolapse+1

+ Pathological Conditions, Signs and Symptoms

+ Pathological Conditions, Anatomical

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, MDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: October 28, 2025

Actual 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 
NCT07215780
Principal SponsorYale University
Study ContactMelissa Markowitz, MDMore contacts
Last updated: December 11, 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 enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ProlapsePathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalPelvic Organ Prolapse

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

10 exclusion criteria prevent from participating
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)

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

One single intervention group is 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.

Study Objectives

Primary Objectives

Secondary Objectives

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 Hospital

Bridgeport, United StatesSee the location
Recruiting

Greenwich Hospital

Greenwich, United States
Recruiting

Yale-New Haven Hospital

New Haven, United States
Recruiting

Lawrence + Memorial Hospital

New London, United States
Recruiting
4 Study Centers