Home Biofeedback vs Pelvic Floor Therapy for Urinary Incontinence

Recruiting at 2 trial locations

Overseen By Jacqueline Noel

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Disqualifiers: Multiple births, Pre-pregnancy pelvic disorder, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

70 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

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 the treatment Home Biofeedback vs Pelvic Floor Therapy for Urinary Incontinence?

Research shows that pelvic floor muscle training (PFMT) is effective for women with stress urinary incontinence, and it is sometimes recommended for mixed and urgency urinary incontinence. Additionally, PFMT combined with biofeedback devices is commonly used for stress urinary incontinence, suggesting potential benefits for home biofeedback devices. ^{1 2 3 4 5}

Is pelvic floor muscle training with home biofeedback devices safe for humans?

Pelvic floor muscle training (PFMT) with home biofeedback devices is generally considered safe for humans, as it is commonly used for treating urinary incontinence and involves exercises to strengthen pelvic muscles. ^{1 3 5 6 7}

How is the treatment 'Home Biofeedback vs Pelvic Floor Therapy for Urinary Incontinence' different from other treatments for urinary incontinence?

This treatment is unique because it uses a home-based biofeedback device, Pericoach®, which allows patients to perform pelvic floor muscle training (PFMT) at home with real-time feedback, potentially offering similar benefits to supervised therapy but with more convenience and privacy. ^{5 8 9 10 11}

What is the purpose of this trial?

Pelvic floor dysfunction is commonly seen in the postpartum women with symptoms including urinary urgency and frequency, urinary incontinence and fecal incontinence. Pelvic floor physical therapy (PFPT) and home biofeedback devices have been shown to improve pelvic floor symptoms in postpartum and non-postpartum populations, respectively. This randomized noninferiority clinical trial will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback or pelvic floor physical therapy.

Research Team

Jessica Sassani, MD

Principal Investigator

Allegheny Health Network

Eligibility Criteria

This trial is for postpartum women who have given birth vaginally (first-time or multiple births) and are experiencing urinary incontinence. They must be willing to do PFPT or home biofeedback exercises, own a smartphone with Bluetooth, and have noticed urine leakage between 4-8 weeks after giving birth. Women with multiple births, preterm delivery at ≤34 weeks, prior surgeries for incontinence or pelvic organ prolapse, or known pelvic floor disorders before pregnancy cannot participate.

Inclusion Criteria

I have experienced urinary leakage within the last two weeks, 4-8 weeks after giving birth.

After giving birth through the vagina, whether it was the first time or not, and whether it was a natural birth or assisted with tools.

I am willing to do special exercises at home or with a therapist.

Exclusion Criteria

I had issues like urinary incontinence before getting pregnant.

I had twins or more, or gave birth at 34 weeks or earlier.

I have had surgery for urinary incontinence or pelvic organ prolapse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either home biofeedback or pelvic floor physical therapy for postpartum urinary incontinence

12 weeks

6 sessions (in-person) for PFPT; daily use for biofeedback

Follow-up

Participants are monitored for changes in urinary incontinence-related quality of life and other pelvic floor symptoms

12 months

Treatment Details

Interventions

• Pelvic Floor Physical Therapy
• Pericoach® by Analytica

Trial Overview The study is testing if using a home biofeedback device called Pericoach® can improve life quality related to urinary incontinence as effectively as Pelvic Floor Physical Therapy (PFPT). Postpartum women will be randomly assigned to either the device use at home or therapy sessions.

Participant Groups

Group I: Pelvic Floor Physical Therapy (PFPT) Active Control 1 Intervention

6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation.

Group II: Biofeedback device Active Control 1 Intervention

Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period.

Pelvic Floor Physical Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pelvic Floor Physical Therapy for:

• Urinary incontinence
• Fecal incontinence
• Pelvic organ prolapse
• Chronic pelvic pain

Approved in European Union as Pelvic Floor Physical Therapy for:

• Urinary incontinence
• Fecal incontinence
• Pelvic organ prolapse
• Sexual dysfunction

Approved in Canada as Pelvic Floor Physical Therapy for:

• Urinary incontinence
• Fecal incontinence
• Pelvic organ prolapse

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

Pelvic floor muscle training (PFMT) is highly effective for women with stress urinary incontinence (UI), showing a significant cure rate with a relative risk (RR) of 8.38 based on high-quality evidence from 21 trials involving 1281 women.

For women with any type of urinary incontinence, PFMT also demonstrates moderate quality evidence of being associated with a cure (RR 5.5) or improvement, reinforcing its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Dumoulin, C., Hay-Smith, J., Habée-Séguin, GM., et al.[2022]

In a study of 49 women undergoing vaginal reconstruction, pelvic floor physical therapy (PFPT) showed initial improvements in muscle function at 12 weeks, but these benefits did not persist by the 24-week follow-up.

Overall quality of life and bladder symptoms improved for all participants by 24 weeks post-surgery, indicating that while PFPT did not provide additional long-term benefits, patients experienced ongoing improvements in their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. Pauls, RN., Crisp, CC., Novicki, K., et al.[2022]

Pelvic floor muscle training (PFMT) significantly improves symptoms of stress urinary incontinence (SUI), with women in PFMT groups being eight times more likely to report a cure compared to those receiving no treatment, based on a systematic review of 31 trials involving 1817 women.

PFMT not only reduces the number of leakage episodes but also enhances quality of life and treatment satisfaction, with rare minor adverse events, suggesting it should be considered a first-line treatment for urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Dumoulin, C., Cacciari, LP., Hay-Smith, EJC.[2023]

Unsupervised behavioral and pelvic floor muscle training (B-PFMT) programs significantly improve urinary incontinence (UI) outcomes and pelvic floor muscle strength in middle-aged women, as shown in a review of 13 studies, including 10 randomized controlled trials.

Two months after the intervention, participants experienced a reduction in incontinent episodes and improved quality of life scores, indicating the effectiveness of B-PFMT for managing UI symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsupervised behavioral and pelvic floor muscle training programs for storage lower urinary tract symptoms in women: a systematic review. Wu, C., Newman, DK., Palmer, MH.[2021]

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 involving over 23,000 pregnant and postnatal women, the app Tät® was found to be effective in improving urinary incontinence symptoms, with 52% of pregnant women and 73% of postnatal women reporting improvements after using the app.

Regular use of pelvic floor muscle training (PFMT) through the app significantly increased the odds of improvement in incontinence symptoms, highlighting the importance of consistent training for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-based pelvic floor muscle training in pregnant and postnatal women: A prospective cohort study exploring factors associated with prevention and improvement of urinary incontinence. Löjdahl, E., Lindam, A., Asklund, I.[2022]

In a study of 10 patients with stress urinary incontinence (SUI), all participants showed clinical improvement after pelvic floor muscle training (PFMT) and self-rehabilitation using a perineal electro-stimulator, indicating its efficacy in managing SUI.

The study found significant increases in the thickness of the levator ani muscles after both conventional rehabilitation and self-rehabilitation, suggesting that self-maintenance exercises enhance the benefits of initial PFMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of at-home self-rehabilitation of the perineum on pelvic floor function in patients with stress urinary incontinence: Results from a prospective study using three-dimensional ultrasound. Legendre, G., Gonzalves, A., Levaillant, JM., et al.[2016]

Home biofeedback is as effective as supervised pelvic floor physical therapy (PFPT) for treating stress urinary incontinence (SUI) in women, with both methods showing significant improvements in quality of life after 3 months.

While home biofeedback was noninferior to PFPT in reducing incontinence severity, PFPT showed greater improvement in overactive bladder symptoms, indicating that both treatments have unique benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial. Barnes, KL., Cichowski, S., Komesu, YM., et al.[2022]

In a study of 64 females aged 6 and older undergoing Pelvic Floor Biofeedback Therapy (PFBT), there was a significant reduction in bladder symptom scores, indicating that PFBT can effectively improve lower urinary tract symptoms (LUTS).

However, only 31% of patients showed a silencing of EMG activity during voiding after treatment, suggesting that while PFBT is beneficial for symptom relief, not all patients achieve the expected physiological response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor biofeedback therapy in children: Assessment of symptom scores in responders and non-responders. Taylor, AS., Cabo, JJ., Lauderdale, C., et al.[2020]

A study involving 30 female patients showed that combining perineal biofeedback with pelvic floor training (PFT) over 6 weeks resulted in better improvement in clinical discomfort from urinary incontinence compared to PFT alone.

Patients receiving only PFT for 3 months experienced good improvement, but it was 10% less effective than the combination treatment, highlighting the added benefit of biofeedback in managing urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineal biofeedback versus pelvic floor training in the treatment of urinary incontinence. Ceresoli, A., Zanetti, G., Seveso, M., et al.[2016]

An intensive pelvic floor muscle training (PFMT) program, assisted by EMG-biofeedback, significantly improved urinary incontinence symptoms in 263 women, with 95% reporting symptom improvement and a notable increase in pelvic floor muscle strength after training.

Long-term follow-up (average 2.8 years) showed that 71% of participants maintained their improvement, highlighting the program's effectiveness in reducing the need for surgical interventions for urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMG-biofeedback assisted pelvic floor muscle training is an effective therapy of stress urinary or mixed incontinence: a 7-year experience with 390 patients. Dannecker, C., Wolf, V., Raab, R., et al.[2019]

References

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

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. [2022]

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

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Unsupervised behavioral and pelvic floor muscle training programs for storage lower urinary tract symptoms in women: a systematic review. [2021]

5. 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]

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

App-based pelvic floor muscle training in pregnant and postnatal women: A prospective cohort study exploring factors associated with prevention and improvement of urinary incontinence. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Impact of at-home self-rehabilitation of the perineum on pelvic floor function in patients with stress urinary incontinence: Results from a prospective study using three-dimensional ultrasound. [2016]

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

Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial. [2022]

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

Pelvic floor biofeedback therapy in children: Assessment of symptom scores in responders and non-responders. [2020]

10. Italy pubmed.ncbi.nlm.nih.gov

Perineal biofeedback versus pelvic floor training in the treatment of urinary incontinence. [2016]

11. Germany pubmed.ncbi.nlm.nih.gov

EMG-biofeedback assisted pelvic floor muscle training is an effective therapy of stress urinary or mixed incontinence: a 7-year experience with 390 patients. [2019]