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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:

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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 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

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

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 more

Awards & 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.

0 / 3Eligibility criteria met