BridgeMD
New treatment option for Urinary Incontinence
Official title Training for Urinary Leakage Improvement After Pregnancy
ClinicalTrials.gov ID: NCT06411158
What this study is testing
- What it's testing
- This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment. TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3).
- 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
- ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum
- At increased risk of sustained pelvic floor disorders, as defined by
- neonate ≥3.5kg, and/or
- operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
- ≥2nd-degree perineal laceration
You likely can't join if
- Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
- Stillbirth or significant maternal or neonatal illness
- Non-English or non-Spanish speaking
- Perineal wound breakdown or cloaca observed on exam
- Severe pain with assessments of PFM integrity and/or strength/function
- Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
See the full eligibility criteria
- ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum
- At increased risk of sustained pelvic floor disorders, as defined by
- neonate ≥3.5kg, and/or
- operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
- ≥2nd-degree perineal laceration
- Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.
- Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
- Stillbirth or significant maternal or neonatal illness
- Non-English or non-Spanish speaking
- Perineal wound breakdown or cloaca observed on exam
- Severe pain with assessments of PFM integrity and/or strength/function
- Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
- Unwilling or unable to upload and use external smartphone app(s)
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Chicago, Illinois, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 San Diego, California, United States; Chicago, Illinois, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States; Providence, Rhode Island, United States; Dallas, Texas, 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.