Home Pelvic Floor Trainer for Pelvic Floor Dysfunction

(HoPE FIT Trial)

Overseen By Kelly Harris, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Physical therapy, Severe developmental delay, Nonverbal, Congenital GU anomaly, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain. Investigators will test the utility of this device as a treatment alternative and/or temporary treatment for a patient's symptoms prior to or perhaps in lieu of their physical therapy appointment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but starting a new medication during the study will lead to exclusion from the trial.

Is the Home Pelvic Floor Trainer safe for humans?

Research indicates that pelvic floor biofeedback therapy, which includes home pelvic floor trainers, is generally safe for conditions like urinary incontinence and pelvic floor dysfunction. These devices are designed to help improve muscle function and are used successfully by individuals at home. ^{1 2 3 4 5}

How is the Home Pelvic Floor Trainer treatment different from other treatments for pelvic floor dysfunction?

The Home Pelvic Floor Trainer is unique because it uses a vaginal sensor and a smartphone app to provide biofeedback, helping users perform pelvic muscle exercises effectively at home. This approach is different from traditional methods as it offers real-time feedback and motivation, making it easier for individuals to continue their exercises consistently. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Home Pelvic Floor Trainer for Pelvic Floor Dysfunction?

Research shows that using home pelvic floor trainers, like the PeriCoach system, can improve pelvic floor muscle strength and reduce symptoms of pelvic floor dysfunction, such as urinary incontinence, in women. These devices often use biofeedback technology, which helps users perform exercises correctly and consistently, leading to better outcomes. ^{1 4 10 11 12}

Who Is on the Research Team?

Kelly Harris, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic prostatitis/pelvic pain syndrome, pelvic floor dysfunction, pelvic pain, or urinary incontinence. Specific eligibility criteria are not provided but typically would include those who can safely use the home pelvic floor trainer.

Inclusion Criteria

I have trouble urinating but don't suffer from chronic pelvic pain.

I experience chronic pain in my pelvic area, with or without issues during urination.

I experience daytime or nighttime bedwetting, frequent urination, urgency, or painful urination.

Exclusion Criteria

I have seen a physical therapist for pelvic floor issues in the last year.

I have a severe developmental delay and may need help with daily activities.

I cannot speak or effectively communicate my needs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the home pelvic floor trainer daily for 2 months to improve pelvic floor dysfunction symptoms

8 weeks

Initial urology consult visit, 4-week, and 8-week visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home Pelvic Floor Trainer

Trial Overview The study is testing a home biofeedback device designed to improve symptoms of pelvic floor dysfunction and associated conditions. It aims to evaluate if this device can be an effective treatment on its own or as a supplement to physical therapy.

How Is the Trial Designed?

Group I: Voiding Dysfunction Experimental Treatment 1 Intervention

Patients with voiding dysfunction only and no pelvic pain symptoms will use the home pelvic floor trainer daily for 2 months.

Group II: Pelvic pain Experimental Treatment 1 Intervention

Patients with pelvic pain with or without voiding dysfunction symptoms will use the home pelvic floor trainer daily for 2 months.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

Pelvic floor biofeedback therapy is a safe and effective treatment for conditions like chronic constipation, urinary incontinence, fecal incontinence, and pelvic floor pain, particularly for patients without severe pelvic organ prolapse or neurogenic defects.

The therapy's success is enhanced when patients have good mental cognition and adhere to treatment, with training focusing on muscle targeting, coordination, and strength, and its effectiveness evaluated through various symptoms and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. Ding, S.[2018]

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]

Citations

1. Brazil pubmed.ncbi.nlm.nih.gov

Home exercises for pelvic floor in continent women one year after physical therapy treatment for urinary incontinence: an observational study. [2019]

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

Comparison of In-person FPMRS-directed Pelvic Floor Therapy Program Versus Unsupervised Pelvic Floor Exercises Following Prostatectomy. [2023]

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

Commercially Available Home Pelvic Training Devices for the Treatment of Pelvic Floor Disorders: A Systematic Review and Meta-analysis. [2022]

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

Pelvic Muscle Exercises Using A Home Trainer for Pelvic Muscle Dysfunction: A Case Report. [2017]

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

The Adherence of Home Pelvic Floor Muscles Training Using a Mobile Device Application for Women With Urinary Incontinence: A Randomized Controlled Trial. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. [2018]

7. Australia pubmed.ncbi.nlm.nih.gov

Development of a core data set for pelvic floor disorder patients registry. [2021]

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

Efficacy of FemiScan Pelvic Floor Therapy for the Treatment of Urinary Incontinence. [2019]

9. Australia pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

The effect of biofeedback pelvic floor training with ACTICORE1 on urinary incontinence: a multicenter randomized clinical pilot trial. [2023]

11. China pubmed.ncbi.nlm.nih.gov

Therapeutic effect of proprioception training combined with pelvic floor electrical stimulation biofeedback on postpartum pelvic floor dysfunction. [2023]

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

Pelvic floor muscle rehabilitation using biofeedback. [2022]