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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of this treatment for urinary incontinence after pregnancy?

Research shows that pelvic floor muscle training (PFMT) combined with biofeedback devices can help improve stress urinary incontinence. A study found that using a home biofeedback device for PFMT was more effective than PFMT alone in managing stress urinary incontinence in women. ^{1 2 3 4 5}

Is the leva device safe for use in humans?

The research does not provide specific safety data for the leva device, but pelvic floor muscle training (PFMT) with biofeedback devices is commonly used and generally considered safe for stress urinary incontinence. ^{1 5 6 7 8}

How is the leva device treatment for urinary incontinence after pregnancy different from other treatments?

The leva device treatment is unique because it combines home pelvic floor exercises with a biofeedback device that guides users, making it easier to perform the exercises correctly and consistently. This approach helps overcome the common issue of low motivation in patients to continue pelvic floor muscle training on their own. ^{1 5 6 9 10}

Research Team

David Rahn, MD

Principal Investigator

UTSW

Marie Gantz, PhD

Principal Investigator

RTI International

Eligibility Criteria

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 over 18, recently had my first child by vaginal delivery after 32 weeks, and it's been about 6 weeks.

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

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

Treatment Details

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.

Participant Groups

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: Interventionist-guided training Active Control 1 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® 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.

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

References

1. Ireland 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of home biofeedback training on stress incontinence. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

Urinary incontinence and prostate cancer: a progressive rehabilitation program design. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Pelvic Floor Muscle Training With Smartphone Reminders on Women in the Postpartum Period: A Randomized Controlled Trial. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Device to promote pelvic floor muscle training for stress incontinence. [2019]

6. United States 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Self-management of incontinence using a free mobile app: factors associated with improvement. [2022]

9. United States 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. [2018]

10. England 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. [2021]