BridgeMD
New treatment option for Pelvic Organ Prolapse
Official title SORE Study: Sitz Baths After Urogynecologic Reconstruction
ClinicalTrials.gov ID: NCT07215780
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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)...
- Surgery to be performed by a urogynecologist
- Ambulatory or inpatient surgery acceptable
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bridgeport, Connecticut, United States
- Greenwich, Connecticut, United States
- New Haven, Connecticut, United States
- New London, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bridgeport, Connecticut, United States; Greenwich, Connecticut, United States; New Haven, Connecticut, United States; New London, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.