Sitz Baths for Pelvic Organ Prolapse

(SORE Trial)

Recruiting at 3 trial locations

Overseen By Koray Gorkem Sacinti, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Opioids

Disqualifiers: Mesh repair, Genital infections, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether sitz baths (warm water soaks) can reduce pain after surgery for pelvic organ prolapse, a condition where pelvic organs drop from their normal position. Participants will either follow a nightly sitz bath routine along with usual care or receive only usual care after surgery. The goal is to determine if sitz baths ease recovery and should be included in pain management plans. Women who have undergone surgery for pelvic organ prolapse and can speak English may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgical care for others.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who use opioids daily. It's best to discuss your specific medications with the trial team.

What prior data suggests that sitz baths are safe for postoperative recovery?

Research has shown that sitz baths are generally safe. They are often recommended for recovery after surgeries, such as those for pelvic organ prolapse. Studies indicate a low risk of side effects with sitz baths. However, improper cleaning of the tub or bath can lead to a small chance of infection. Some reports mention rare cases of skin burns from excessively hot water. Overall, sitz baths are considered a safe and effective method to aid healing and relieve pain after surgery, provided that clean equipment and warm, not hot, water are used. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sitz baths for pelvic organ prolapse because they offer a simple, non-invasive option that can be easily incorporated into daily routines. Unlike more invasive treatments like surgery or pessaries, sitz baths involve soaking in warm water, which may help alleviate symptoms without the need for medical devices or procedures. This method is appealing because it emphasizes comfort and convenience, potentially offering relief without the side effects associated with more aggressive treatments. Additionally, sitz baths could complement usual care, enhancing overall management of the condition.

What evidence suggests that sitz baths are effective for postoperative pain management in pelvic organ prolapse?

Research has shown that sitz baths, which are warm water soaks, may help reduce pain after surgery for pelvic organ prolapse. In this trial, participants will receive either sitz baths plus usual care or usual care alone. Studies have found that these baths can ease discomfort without any extra ingredients. In some cases, mucosal prolapse, a condition where tissue protrudes abnormally, improved after one week of sitz baths combined with other treatments. While more research is needed, early results are promising for using sitz baths to manage post-surgical pain. ^{3 6 7 8 9}

Who Is on the Research Team?

Nancy Ringel, MD, MS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

The SORE Study is for individuals who have undergone surgical repair of pelvic organ prolapse. Participants should be in the postoperative phase and interested in evaluating the effectiveness of sitz baths as a pain management strategy.

Inclusion Criteria

English-speaking

I am a woman aged 18 or older.

I am eligible for both outpatient and inpatient surgery.

Exclusion Criteria

Lack of access to operative report

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical repair of pelvic organ prolapse followed by a 7-day regimen of sitz baths or usual care

1 week

Daily sitz baths at home

Follow-up

Participants are monitored for pain intensity, satisfaction, opioid use, and adverse effects

Up to 90 days

Regular follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Sitz Baths

Trial Overview This study tests whether sitz baths can help reduce pain after surgery for pelvic organ prolapse compared to usual care. It's a controlled trial where patients are randomly assigned to either take sitz baths or receive standard postoperative care.

How Is the Trial Designed?

Group I: Sitz baths plus usual care Experimental Treatment 1 Intervention

Warm water sitz baths plus usual care. 7-day nightly regimen of warm water soaks without additives.

Group II: Usual care Active Control 1 Intervention

Care as usual

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

American Urogynecologic Society

Collaborator

Trials

11

Recruited

690+

Citations

1. withpower.com withpower.com/trial/phase-pelvic-organ-prolapse-9-2025-f5e46

Sitz Baths for Pelvic Organ Prolapse (SORE Trial) Trial Overview This study tests whether sitz baths can help reduce pain after surgery for pelvic organ prolapse compared to usual care. It's a controlled trial ...

2. patlynk.com patlynk.com/trial/NCT07215780

Sitz Baths for Postoperative Pain After Urogynecologic ... This study focuses on helping women who have undergone surgery to repair pelvic organ prolapse, a condition where organs like the bladder or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12226706/

Postpartum Anorectal and Pelvic Floor Disorders: Evaluation ... Recent advances include dynamic 3D and 4D ultrasound of the pelvic floor to reveal pathology, anal sphincter defects, and pelvic organ prolapse.

4. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-024-02742-3

Mid-term outcomes of moderate-severe cystocele repairing ... Autologous fascia lata for cystocele treatment shows promising mid-term outcomes, safely and effectively enhancing QoL with high satisfaction.

5. researchgate.net researchgate.net/publication/7762878_Sitz_Bath_Where_Is_the_Evidence_Scientific_Basis_of_a_Common_Practice

Sitz Bath: Where Is the Evidence? Scientific Basis of a ... The effectiveness of sitz bath ... The mucosal prolapse regressed after 1 week's treatment with topical estrogen and antibiotics and sitz baths.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11580651/

Efficacy and safety of Le Fort colpocleisis in the treatment ... Le Fort colpocleisis is an obliterative surgery for the treatment of pelvic organ prolapse (POP). In this study, we aimed to investigate the ...

7. healthline.com healthline.com/health/sitz-bath

Sitz Bath: Uses, Procedure, and Risk Factors Sitz baths are typically safe, but there is a slight risk for infection if the tub or plastic bath is not thoroughly clean. It's also important to ensure the ...

8. ndnr.com ndnr.com/womens-health/the-sitz-bath-in-gynecology/

The Sitz Bath in Gynecology - This article focuses specifically on the sitz bath for use in gynecological conditions, highlighting it as one of the most effective and safest treatments in ...

9. trialstoday.org trialstoday.org/trial/NCT07215780

SORE Study: Sitz Baths After Urogynecologic Reconstruction Purpose. The purpose of this study is to evaluate the utility of postoperative sitz baths in patient pain perception and recovery following ...