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NCT06411158 · ClinicalTrials.gov registry record · NA
Training for Urinary Leakage Improvement After Pregnancy
A NA study of Urinary Incontinence and Delivery Complication, sponsored by NICHD Pelvic Floor Disorders Network.
- Recruiting
- Registry status
- NA
- Development phase
- 216
- Enrollment target
- 7
- Study locations
NCT06411158: Recruiting NA study of Urinary Incontinence and Delivery Complication, sponsored by NICHD Pelvic Floor Disorders Network.
NCT06411158 is a NA study of Urinary Incontinence and Delivery Complication that is actively recruiting participants, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 216 participants, below the 258-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (16% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06411158, a NA study of Urinary Incontinence and Delivery Complication, is actively recruiting participants, sponsored by NICHD Pelvic Floor Disorders Network.
- RECRUITING
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
- 7
- Study locations
Study Summary
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). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®). The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.
Primary Outcome
The primary outcome is change in urinary incontinence (UI) as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), comparing scores from baseline to 6 months postpartum. This instrument consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage. ICIQ-SF scores range from 0 (no leakage or bother) to 21 (worst leakage, most bothersome).
Conditions Studied
Interventions
- OTHER Education
- OTHER Interventionist-guided training
- DEVICE Home pelvic floor exercises guided by the leva® device
Study Locations (7)
California
- Kaiser Permanente -- San Diego - San Diego
- University of California - San Diego - San Diego
Illinois
- University of Chicago - Chicago
North Carolina
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery - Durham
Pennsylvania
- University of Pennsylvania - Philadelphia
Rhode Island
- Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery - Providence
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2024-11-12 |
| Est. Completion | 2027-11-12 |
| Phase | NA |
What NCT06411158 shows while recruiting
NCT06411158 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 258-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (16% lower).
The record links to 2 conditions, with Urinary Incontinence appearing as the primary indexed condition, and to 3 interventions - of which Education is the first listed.
NCT06411158 lists 7 locations in 6 states (California, Illinois, North Carolina).
Frequently Asked Questions
What is clinical trial NCT06411158 about?
NCT06411158 is a clinical study titled "Training for Urinary Leakage Improvement After Pregnancy". 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 ...
What is the current status of trial NCT06411158?
This trial is currently recruiting. It is a NA study. The enrollment target is 216 participants. The study started on 2024-11-12. Estimated completion is 2027-11-12.
What conditions does trial NCT06411158 study?
This clinical trial studies the following conditions: Urinary Incontinence, Delivery Complication.
What interventions are being tested in trial NCT06411158?
The interventions under investigation include: Education (OTHER), Interventionist-guided training (OTHER), Home pelvic floor exercises guided by the leva® device (DEVICE).
Who is sponsoring clinical trial NCT06411158?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06411158 being conducted?
This trial has 7 study locations across California, Illinois, North Carolina, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06411158's enrollment target sits among peer trials
216 15th of 48 higher than 34 of 48 other Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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