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Behavioural Intervention
Training for Urinary Incontinence After Pregnancy (TULIP Trial)
N/A
Recruiting
Led By David Rahn, MD
Research Sponsored by NICHD Pelvic Floor Disorders Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Inability to follow in-person or home PFMT instructions
Perineal wound breakdown or cloaca observed on exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 months to 12 months postpartum
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of two different treatments on postpartum women who have urinary incontinence. The study will involve 216 women who are at high risk for pelvic floor disorders. The
Who is the study for?
This trial is for new mothers who have just had their first child and are experiencing urinary incontinence. Participants should be at high risk for long-term pelvic floor disorders but able to undergo nonsurgical treatments.
What is being tested?
The study compares two active interventions against a control group receiving only education. One group will do pelvic floor muscle training, another will use the leva® biofeedback device at home, and the third gets educational materials.
What are the potential side effects?
Since this trial involves non-surgical methods like exercise and education, side effects may include temporary muscle soreness from pelvic exercises or discomfort using the leva® device.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot follow instructions for pelvic floor muscle training at home or in-person.
Select...
I have a wound or opening in the perineal area.
Select...
I do not speak English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 6 months to 12 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months to 12 months postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Adherence to interventions
Change in Lower Urinary Tract Dysfunction Research Network Symptom Index (LURN-SI-10) score
Change in Patient Global Impression of Improvement (PGI-I) score
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: EducationExperimental Treatment1 Intervention
Education will be provided on pelvic floor muscle function and continence mechanisms. No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises.
Group II: Interventionist-guided trainingActive Control1 Intervention
Interventionist-guided training at baseline, followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session, and then continued HEP. Home exercises will be encouraged/ augmented using a PFDN research smartphone app.
Group III: Home pelvic floor exercises guided by the leva® deviceActive Control1 Intervention
Home pelvic floor exercises guided by the leva® device and its accompanying app/software for gradually increasing strength and duration of pelvic floor contractions. The PFDN research smartphone app will have weekly queries of whether exercises were completed.
Find a Location
Who is running the clinical trial?
RTI InternationalOTHER
197 Previous Clinical Trials
939,932 Total Patients Enrolled
4 Trials studying Urinary Incontinence
1,374 Patients Enrolled for Urinary Incontinence
NICHD Pelvic Floor Disorders NetworkLead Sponsor
15 Previous Clinical Trials
4,650 Total Patients Enrolled
7 Trials studying Urinary Incontinence
2,283 Patients Enrolled for Urinary Incontinence
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,238 Total Patients Enrolled
13 Trials studying Urinary Incontinence
3,146 Patients Enrolled for Urinary Incontinence
University of ChicagoOTHER
1,062 Previous Clinical Trials
839,918 Total Patients Enrolled
2 Trials studying Urinary Incontinence
528 Patients Enrolled for Urinary Incontinence
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,726,832 Total Patients Enrolled
9 Trials studying Urinary Incontinence
2,131 Patients Enrolled for Urinary Incontinence
Duke UniversityOTHER
2,463 Previous Clinical Trials
2,981,644 Total Patients Enrolled
6 Trials studying Urinary Incontinence
1,689 Patients Enrolled for Urinary Incontinence
Kaiser PermanenteOTHER
556 Previous Clinical Trials
27,732,520 Total Patients Enrolled
10 Trials studying Urinary Incontinence
4,225 Patients Enrolled for Urinary Incontinence
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,525 Total Patients Enrolled
12 Trials studying Urinary Incontinence
6,288 Patients Enrolled for Urinary Incontinence
University of Texas Southwestern Medical CenterOTHER
1,089 Previous Clinical Trials
1,059,467 Total Patients Enrolled
4 Trials studying Urinary Incontinence
1,201 Patients Enrolled for Urinary Incontinence
Women and Infants Hospital of Rhode IslandOTHER
114 Previous Clinical Trials
40,134 Total Patients Enrolled
8 Trials studying Urinary Incontinence
2,387 Patients Enrolled for Urinary Incontinence