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Behavioural Intervention

Training for Urinary Incontinence After Pregnancy (TULIP Trial)

N/A
Waitlist Available
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

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:
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I cannot follow instructions for pelvic floor muscle training at home or in-person.
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I have a wound or opening in the perineal area.
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I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months to 12 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 months to 12 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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 more

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-designed smartphone app that will offer reminder notifications to conduct exercises.
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-designed smartphone app will offer reminder notifications to conduct exercise and weekly queries of whether exercises were completed.

Find a Location

Who is running the clinical trial?

RTI InternationalOTHER
190 Previous Clinical Trials
810,487 Total Patients Enrolled
3 Trials studying Urinary Incontinence
1,016 Patients Enrolled for Urinary Incontinence
NICHD Pelvic Floor Disorders NetworkLead Sponsor
14 Previous Clinical Trials
4,292 Total Patients Enrolled
6 Trials studying Urinary Incontinence
1,925 Patients Enrolled for Urinary Incontinence
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,307 Total Patients Enrolled
12 Trials studying Urinary Incontinence
2,788 Patients Enrolled for Urinary Incontinence
~144 spots leftby Jun 2027
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