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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home biofeedback device designed to assist those with pelvic floor dysfunction, which can lead to pelvic pain or urination problems. The device, known as the Home Pelvic Floor Trainer, offers a potential alternative or temporary solution before starting physical therapy. Participants will be divided into two groups: one experiencing pelvic pain and the other dealing with voiding difficulties. Suitable candidates have symptoms like frequent urination or pelvic pain and have not consulted a physical therapist for these issues in the past year. As an unphased trial, this study provides participants the opportunity to explore innovative solutions for pelvic floor issues before considering traditional therapies.

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.

What prior data suggests that this device is safe for pelvic floor dysfunction?

Research has shown that pelvic floor biofeedback therapy, which includes home pelvic floor trainers, is generally safe for conditions like urinary incontinence. Users of these devices typically do not experience serious side effects. One study on pelvic floor rehabilitation found positive results for treating urinary symptoms and pelvic pain, with patients rating their success highly. This suggests that the treatment is well-tolerated. Overall, evidence indicates that home pelvic floor trainers are a safe option for managing pelvic floor issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Home Pelvic Floor Trainer is unique because it empowers patients to manage pelvic floor dysfunction from the comfort of their homes. Unlike traditional treatments that often require in-person sessions with a therapist, this device offers a convenient, daily exercise routine that patients can integrate into their regular schedules. Researchers are excited about this treatment because it has the potential to improve accessibility and adherence, offering a more personalized and consistent approach to managing symptoms like pelvic pain and voiding dysfunction.

What evidence suggests that this device is effective for pelvic floor dysfunction?

Research shows that a home biofeedback device for pelvic floor issues holds promise. Studies have found an average success rate of 8 out of 10 in reducing urinary symptoms and pelvic pain. One study found that combining biofeedback with pelvic floor exercises was more effective than exercises alone. This trial will evaluate the home pelvic floor trainer as a potential tool for managing pelvic pain and urinary problems. These findings suggest that this device might be an effective treatment option. ^{1 2 3 4 6}

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

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06909539

NCT06909539 | HOme PElvic Floor Improvement Trainer ... This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5323296/

Prospective Outcomes of a Pelvic Floor Rehabilitation ... The median success rating was 8, 8, and 7 for treatment of urinary symptoms, pelvic pain/dyspareunia, and bowel symptoms, respectively. Conclusions. An ...

3. withpower.com withpower.com/trial/phase-pelvic-pain-3-2025-eb198

Home Pelvic Floor Trainer for Pelvic Floor Dysfunction · ... This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain.

4. 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.

5. trial.medpath.com trial.medpath.com/clinical-trial/b692bf6b98a2e11d/nct06909539-perineometer-gamification-pediatric-pelvic-floor-dysfunction

HOme PElvic Floor Improvement Trainer Trial | MedPath This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction/voiding dysfunction and pelvic pain.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937824000061

Pelvic floor muscle training as treatment for female sexual ... Four studies were included in the meta-analysis showing that pelvic floor muscle training improved arousal (1.49; 95% confidence interval, 0.13–2.85), orgasm ( ...