Pelvic Organ ProlapseSORENCT07215780
SORE Study: Sitz Baths After Urogynecologic Reconstruction
A study testing Sitz Bath in people with Pelvic Organ Prolapse and Postoperative Pain Management, run by Yale University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Postoperative Pain Management, Gynecologic Surgeries
- What is being tested?
- Sitz Bath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ambulatory or inpatient surgery acceptable
Who cannot join
- 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)
- Concurrent non-urogynecologic surgery (i.e. rectopexy, staging or debulking for malignancy)
- Lack of access to operative report
Show all 10Show fewer
- Pregnant (as determined by positive urine pregnancy test on the day of surgery via standard testing or current pregnancy documented in the preoperative note)
- Incarcerated
- Unable to give consent/conserved
- Unable to complete study intervention or assessment per investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06520
About this study
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.
Read the detailed description
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.
- Being tested
- Sitz Bath
- Keywords
- Pelvic organ prolapse surgical repair
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitz BathDevice
Warm water sitz bath, 7 nights, 10 minutes each
| Study group | Role | What they receive |
|---|---|---|
| Sitz baths plus usual care | Experimental | Warm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives. Receives: Device: Sitz Bath |
| Usual care | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7 Post surgery
Secondary outcomes (10)
Mean score patient satisfaction
Satisfaction with postoperative pain management on a 0-100 mm visual analog scale
Measured: Day 7 Post surgery
Mean Oxycodone use
Mean number of oxycodone tablets used postoperatively
Measured: 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)
Measured: 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)
Measured: Day 7 Post surgery
Sitz bath use- Adherence
Total use of sitz baths in minutes
Measured: Day 7 Post surgery
Barriers to use- Adherence
Number of barriers to use perceived by self-report
Measured: Day 7 Post surgery
Number of participants with rare adverse effects
Number of participants with any rare adverse effects per protocol
Measured: Day 7 Post surgery
Mean Opioid use
Mean number of requests for opioid refills postoperatively
Measured: 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
Measured: 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
Measured: Up to Day 90 Post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start28 Oct 2025
- Primary completion27 Aug 2026
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study population will consist of adult patients undergoing native tissue surgical repair of pelvic organ prolapse at a Yale-affiliated hospital.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Urogynecologic Society
- Responsible party
- Sponsor
- Investigators
- Nancy Ringel, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215780
- Sponsor's protocol ID
- 2000040422
- Acronym
- SORE
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SORE Study: Sitz Baths After Urogynecologic Reconstruction
- ClinicalTrials.gov ID
- NCT07215780
- Acronym / sponsor ID
- SORE / 2000040422
- Keywords
- Pelvic organ prolapse surgical repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Urogynecologic Society
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 27 Aug 2026 (actual)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population will consist of adult patients undergoing native tissue surgical repair of pelvic organ prolapse at a Yale-affiliated hospital.
| Arm | Type | Receives |
|---|---|---|
| Sitz baths plus usual care | Experimental | Device: Sitz BathWarm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives. |
| Usual care | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Ambulatory or inpatient surgery acceptable
Key exclusion criteria (10 listed)
- 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)
- Concurrent non-urogynecologic surgery (i.e. rectopexy, staging or debulking for malignancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitz BathWarm water sitz bath, 7 nights, 10 minutes each | Device | Sitz baths plus usual care |
Primary outcome
Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire
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.
10 secondary outcomes
Mean score patient satisfaction
Time frame: Day 7 Post surgery
Mean Oxycodone use
Time frame: Day 7 Post surgery
Comfort with postoperative pain plan
Time frame: Day 7 Post surgery
Comfort with postoperative pain plan using Sitz bath
Time frame: Day 7 Post surgery
Sitz bath use- Adherence
Time frame: Day 7 Post surgery
Barriers to use- Adherence
Time frame: Day 7 Post surgery
Number of participants with rare adverse effects
Time frame: Day 7 Post surgery
Mean Opioid use
Time frame: Day 7 Post surgery
Mean number of calls regarding pain
Time frame: Up to Day 90 Post surgery
Mean number of Emergency Department visits
Time frame: Up to Day 90 Post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Ringel, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitz Bath in people with Pelvic Organ Prolapse and Postoperative Pain Management, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS-PI) short form 3a questionnaire (time frame: Day 7 Post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.