Home Biofeedback vs Pelvic Floor Therapy for Urinary Incontinence

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to assist new mothers experiencing urinary leakage after childbirth. One group will use a biofeedback device at home, called Pericoach® by Analytica, to exercise pelvic muscles. The other group will attend pelvic floor physical therapy, which involves special exercises guided by a therapist. The trial aims to determine if home exercises with the device are as effective as therapy sessions. Women who are a few weeks postpartum, have given birth vaginally, and have noticed urine leaks may be suitable for this trial. Participants must also have access to a smartphone with Bluetooth to use the device. As an unphased trial, this study offers participants the chance to contribute to understanding and improving postpartum care options.

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 prior data suggests that these treatments are safe for urinary incontinence?

Previous studies have shown that pelvic floor physical therapy (PFPT) is well-received by patients. Research indicates that both guided and self-guided PFPT effectively reduce symptoms of urinary incontinence (UI) without major safety concerns.

For Pericoach®, a device providing feedback during exercises, studies found it safe, with no serious device-related issues. Although a few users experienced urinary tract infections, such cases were rare. Overall, the device has been used safely to strengthen pelvic floor muscles and treat various types of incontinence.

Both treatment options in this study have been used before, focusing on safety and improving quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for urinary incontinence because they offer unique approaches compared to standard options like medication or surgery. Pelvic Floor Physical Therapy (PFPT) involves structured sessions with a therapist, along with home exercises, which can provide personalized rehabilitation without invasive procedures. Meanwhile, the Pericoach® by Analytica is a biofeedback device that offers a novel delivery method by being a discreet, daily-use vaginal device that helps users engage their pelvic floor muscles more effectively. These approaches provide non-surgical, empowering alternatives that might improve patient adherence and outcomes by making treatment more accessible and engaging.

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

This trial will compare Pelvic Floor Physical Therapy (PFPT) with the use of a home biofeedback device, Pericoach®, for managing urinary incontinence. Studies have shown that PFPT can greatly improve the quality of life for women with urinary incontinence, particularly stress urinary incontinence, with noticeable improvements in just six weeks. Research suggests that home biofeedback devices like the Pericoach® can also help, with about 69% of users experiencing fewer leaks. These devices strengthen the pelvic floor muscles. Both treatments in this trial aim to improve pelvic floor function, which can help manage urinary incontinence symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Jessica Sassani, MD

Principal Investigator

Allegheny Health Network

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10301414/

Effectiveness of Pelvic Floor Muscle Training on Quality ... This study confirmed the effectiveness of PFMT on the QoL in women with UI, mainly for patients with stress urinary incontinence.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6428909/

Effectiveness of pelvic floor muscle training and bladder ... The PFMT and bladder training was effective, with positive results as early as 6 weeks. The protocols tested should be used in primary health centers.

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

Pressure-Mediated Biofeedback With Pelvic Floor Muscle ... In this randomized clinical trial, the efficacy of pressure-mediated BF combined with PFMT was superior to that of PFMT alone.

4. aafp.org aafp.org/pubs/afp/issues/2020/0401/p393.html

Pelvic Floor Muscle Training vs. Control for Urinary ... Use of pelvic floor muscle training to treat women with all subtypes of urinary incontinence results in improvement or cure vs. no treatment.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378512225001847

The feasibility and effects of a telehealth-delivered physical ... This study investigated the feasibility and effectiveness of a telehealth-delivered pelvic floor muscle training program for postmenopausal women with urinary ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725001638

Group-based pelvic floor muscle training for urinary ... This paper reviews the current evidence on group-based PFMT, discusses participant inclusion criteria, details the structure of the 12-week PFMT programme.

7. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009508.pub2/abstract

Comparisons of approaches to pelvic floor muscle training ... Pelvic floor muscle training (PFMT) is a recommended treatment for female stress, urgency, and mixed urinary incontinence. Training varies in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9944784/

Supervised versus unsupervised pelvic floor muscle training ... Supervised and unsupervised PFMT programs can both be effective in treating women's UI if training sessions and regular reassessments are provided.

9. bmj.com bmj.com/content/371/bmj.m3719

Effectiveness of pelvic floor muscle training with ... - The BMJ To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in ...