Training for Urinary Incontinence After Pregnancy

(TULIP Trial)

Recruiting at 6 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NICHD Pelvic Floor Disorders Network

Disqualifiers: Non-English/Spanish, Stillbirth, Severe pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best nonsurgical treatment for urinary incontinence (difficulty holding urine) in women who have recently given birth. It tests two methods: pelvic floor exercises performed at home with a special biofeedback device (leva® device) and exercises guided by a trainer. A third group will receive education about pelvic floor health but no specific exercise instructions. Ideal candidates for this trial are women who have had their first baby vaginally, experienced a difficult delivery, and are dealing with bothersome urinary issues. As an unphased trial, this study provides participants the chance to contribute to important research that may enhance postpartum care for women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pelvic floor muscle training (PFMT) is a common and safe method for managing urinary incontinence. This includes exercises performed at home and those using devices like the leva®. The FDA-approved leva® device helps strengthen pelvic floor muscles and can improve urinary incontinence symptoms.

Studies have found that home-based devices for pelvic floor exercises can reduce the frequency and severity of incontinence episodes. Training guided by a specialist is also well-tolerated. These exercises are non-invasive, meaning they don't involve surgery, and no major safety concerns or side effects have been reported.

Overall, both the leva® device and specialist-guided PFMT are considered safe and effective options for managing postpartum urinary incontinence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for urinary incontinence after pregnancy because they offer innovative ways to strengthen the pelvic floor muscles. Home pelvic floor exercises guided by the leva® device provide a personalized approach using an app that tracks progress and encourages gradual strength improvements, making it more interactive than traditional Kegel exercises. Interventionist-guided training combines professional support with a structured home exercise plan, ensuring that new mothers receive tailored guidance and motivation throughout their recovery. These approaches aim to enhance adherence and effectiveness by leveraging technology and expert support, potentially offering more effective solutions compared to standard self-managed exercises.

What evidence suggests that this trial's treatments could be effective for urinary incontinence after pregnancy?

Research shows that pelvic floor muscle training (PFMT) effectively treats urinary incontinence in women after childbirth. In this trial, participants may perform home pelvic floor exercises guided by the leva® device, which studies have found enhances the effectiveness of these exercises. This device provides guidance and feedback, assisting women in strengthening their pelvic floor muscles at home. Alternatively, participants may receive interventionist-guided training with a professional coach, who offers direct guidance and a structured exercise plan. Both methods aim to reduce symptoms by helping women regain control over their pelvic muscles. In summary, the trial tests the effectiveness of both the home-based leva® device and professional coaching in managing urinary incontinence after childbirth. ^{2 6 7 8 9}

Who Is on the Research Team?

Marie Gantz, PhD

Principal Investigator

RTI International

David Rahn, MD

Principal Investigator

UTSW

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am at high risk for pelvic floor disorders after childbirth.

Exclusion Criteria

Stillbirth or significant maternal or neonatal illness

Unwilling or unable to upload and use external smartphone app(s)

I cannot follow instructions for pelvic floor muscle training at home or in-person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either interventionist-guided pelvic floor muscle training, home biofeedback device training, or education on pelvic floor muscle function

6 months

2 visits (in-person) for interventionist-guided training, ongoing home exercises

Follow-up

Participants are monitored for changes in urinary incontinence and other secondary outcomes

6 months

Monthly questionnaires sent to participants

Extension

Continued monitoring and assessment of adherence to interventions and secondary outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Home pelvic floor exercises guided by the leva® device
• Interventionist-guided training

Trial Overview 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.

How Is the Trial Designed?

Group I: Education Experimental Treatment 1 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: Home pelvic floor exercises guided by the leva® device Active Control 1 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.

Group III: Interventionist-guided training Active Control 1 Intervention

Interventionist-guided training at baseline (i.e., approximately 8 weeks postpartum), followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session approximately 4 weeks later, and then continued HEP. Two exercise sets per day are encouraged between baseline and 6 months postpartum (i.e., time of the primary outcome), followed by at least 3 times-per-week exercise sets until 12 months postpartum. Home exercises will be encouraged using a PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.

Home pelvic floor exercises guided by the leva® device is already approved in United States for the following indications:

Approved in United States as leva device for:

• Stress urinary incontinence
• Urinary incontinence postpartum

Who Is Running the Clinical Trial?

NICHD Pelvic Floor Disorders Network

Lead Sponsor

Trials

16

Recruited

4,900+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Published Research Related to This Trial

In a study of 35 women with urodynamic stress urinary incontinence, those using pelvic floor training (PFT) with a home biofeedback device had a success rate of 68.8% in avoiding surgery after one year, compared to 52.6% in the PFT alone group, although this difference was not statistically significant.

Significant improvements in pelvic floor muscle activity and a decrease in leakage index were observed in the home biofeedback group after 12 weeks, indicating that this method may enhance the effectiveness of pelvic floor training for managing urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of home biofeedback training on stress incontinence. Aukee, P., Immonen, P., Laaksonen, DE., et al.[2004]

A randomized controlled trial with 148 postpartum women showed that using a smartphone app for pelvic floor muscle training (PFMT) significantly increased adherence to the training (53.9% vs 20.8%) compared to a control group without reminders.

While the app improved muscle activation and endurance of pelvic floor muscles, it did not lead to significant changes in symptoms of stress urinary incontinence, indicating that while adherence and muscle performance improved, symptom relief may require additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Pelvic Floor Muscle Training With Smartphone Reminders on Women in the Postpartum Period: A Randomized Controlled Trial. Chu, L., Jin, X., Wu, S., et al.[2023]

A new device designed to support pelvic floor muscle training (PFMT) significantly improved multiple outcomes for women with stress urinary incontinence, including reduced incontinence episodes and improved quality of life, compared to a control group that only received informational pamphlets.

Patients using the device reported feeling more motivated to perform their exercises, with 48% expressing satisfaction with their results, compared to only 15% satisfaction in the control group, highlighting the device's potential effectiveness in encouraging adherence to PFMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device to promote pelvic floor muscle training for stress incontinence. Sugaya, K., Owan, T., Hatano, T., et al.[2019]

The Kegel Exercise Pregnancy Training-app trial will involve 370 pregnant women to evaluate the effectiveness of a mobile app for pelvic floor muscle training (PFMT) in reducing urinary incontinence, with outcomes assessed at multiple time points including 8 weeks postnatal.

The study aims to compare the PFMT intervention against usual care, measuring not only urinary incontinence but also quality of life and adherence to the training, while also analyzing the cost-effectiveness of the app-guided training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol. Sidik, SM., Jaffar, A., Foo, CN., et al.[2021]

Pelvic floor muscle training (PFMT) during pregnancy can significantly reduce the risk of urinary incontinence for up to 6 months after delivery, as shown in a review of 22 trials with 8,485 women.

For postnatal women with existing incontinence, PFMT also appears to help reduce symptoms, but its effectiveness in a mixed group of women (with and without incontinence) is less clear, indicating that targeted PFMT may be more beneficial than a general approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training for prevention and treatment of urinary and fecal incontinence in antenatal and postnatal women: a short version Cochrane review. Boyle, R., Hay-Smith, EJ., Cody, JD., et al.[2018]

A 24-week pelvic floor muscle training program significantly improved urinary incontinence symptoms in 66 participants with prostate cancer, as evidenced by reductions in symptom intensity, frequency, and activity limitations (p≤.0001).

Participants in the experimental group also experienced a notable improvement in waist perimeter (p≤.001) and quality of life, indicating that better management of urinary incontinence can enhance overall well-being (p=.039).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary incontinence and prostate cancer: a progressive rehabilitation program design. Serdà, BC., Marcos-Gragera, R.[2014]

Antenatal pelvic floor muscle training (PFMT) is effective in preventing urinary and fecal incontinence during and after pregnancy, yet it is not widely practiced despite being recommended in guidelines.

The successful implementation of PFMT requires collective action from women, healthcare professionals, and policymakers, highlighting the need for policy reform and organizational support to prioritize women's reproductive health and the prevention of incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing pelvic floor muscle training in women's childbearing years: A critical interpretive synthesis of individual, professional, and service issues. Salmon, VE., Hay-Smith, EJC., Jarvie, R., et al.[2021]

A randomized controlled trial involving women with stress urinary incontinence (SUI) demonstrated that pelvic floor muscle training (PFMT) significantly improved quality of life and reduced the number of pads used over a 12-week period.

The study found no significant differences in outcomes between three different PFMT strategies, indicating that additional electrical stimulation does not provide extra benefits for patients who can voluntarily contract their pelvic floor muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies. Huebner, M., Riegel, K., Hinninghofen, H., et al.[2014]

The study involved 66 women, including 31 with genuine stress incontinence and 35 healthy controls, using an EMG-based device to measure pelvic floor muscle activity during contractions, revealing that incontinent patients had significantly lower muscle activity in the standing position compared to controls.

The findings suggest that pelvic floor muscle activity decreases with age, and while the EMG device may not yet be a fully established diagnostic tool, it shows promise in guiding pelvic floor muscle training for patients with incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of aging on the electromyographic activity of pelvic floor muscles. A comparative study among stress incontinent patients and asymptomatic women. Aukee, P., Penttinen, J., Airaksinen, O.[2019]

In a study of 2,153 women using the Tät® app for pelvic floor muscle training (PFMT), 65.6% reported improvement in urinary incontinence symptoms after 3 months, indicating the app's effectiveness as a self-management tool.

Regular use of the app and frequency of PFMT were key factors predicting both any improvement and significant improvement in symptoms, suggesting that consistent engagement with the app enhances treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of incontinence using a free mobile app: factors associated with improvement. Nyström, E., Söderström, L., Samuelsson, E.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10151990/

Efficacy of supervised pelvic floor muscle training with a ... Supervised pelvic floor muscle training (PFMT) of at least 3 months duration has been strongly recommended as a first-line treatment for women ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04508153?term=REN001&viewType=Table&rank=7

Pelvic Floor Muscle Training With a Digital Therapeutic ... Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence.

3. levacares.com levacares.com/for-hcps/how-leva-works/

How Leva Therapy Works| Leva Pelvic Health System Learn how Leva works: an FDA-cleared pelvic floor device for effective at-home training to treat urinary and chronic fecal incontinence.

4. axenahealth.com axenahealth.com/2024/09/axena-healths-leva-system-in-clinical-trial-to-compare-first-line-treatments-for-postpartum-urinary-incontinence/

Axena Health's Leva System in Clinical Trial to Compare ... The Leva Pelvic Health System offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825641

Pressure-Mediated Biofeedback With Pelvic Floor Muscle ... Pelvic floor muscle training for prevention and treatment of urinary incontinence during pregnancy and after childbirth and its effect on ...

6. levacares.com levacares.com/

Leva Therapy | The Leva Pelvic Health System Discover the Leva Pelvic Health System, an effective at-home solution to strengthen pelvic floor muscles and manage urinary incontinence.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/24/NCT06152224/Prot_SAP_000.pdf

Use of the LEVA® Pelvic Health System for Fecal ... It is also FDA-cleared for the rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild-to-moderate ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K213913.pdf

June 30, 2022 Renovia Inc. Jacqueline Schmainda ... The leva Pelvic Health System is intended for: 1) Strengthening of the pelvic floor muscles;. 2) Rehabilitation and training of weak pelvic.

9. journals.lww.com journals.lww.com/jcma/fulltext/2022/04000/home_based_noninvasive_pelvic_floor_muscle.11.aspx

Home-based noninvasive pelvic floor muscle training ... The data demonstrated that 3 months of Kegel exercise assisted with a home-based PFMT device improved the number and severity of episodes, PVR, and quality of ...