Home Pelvic Floor Improvement Trainer for kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will evaluate a home pelvic floor trainer device designed to help children with pelvic floor dysfunction and voiding symptoms. The device uses biofeedback and is intended as an at-home treatment option or temporary substitute before or instead of traditional physical therapy. Eligible participants are youths aged 8 to 18 who have dysfunctional voiding with or without chronic pelvic pain and who use Apple devices for the app. The study will monitor device adherence, usability, urinary function outcomes, and changes in pelvic pain. Data will be collected at the site and through parental or patient reports to gauge feasibility and potential benefits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* English-speaking only.
* Dysfunctional voiding symptoms without chronic pelvic pain.
* Chronic pelvic pain with or without dysfunctional voiding symptoms (daytime enuresis, nocturnal enuresis, frequency, urgency, dysuria)
* 8 years - 18 years, no one under 8 and no one over 18.
* Patient received PVR and uroflow at initial urology consult visit.
* Patient or parent has an Apple product (ie: iPhone, or tablet). The application is only available via Apple products.

Exclusion Criteria:

* Non-English speaking.
* Has seen a physical therapist for traditional physical therapy of the pelvic floor due to urinary symptoms or chronic pelvic pain within the last 12 months.

Note: This would include patients who begin physical therapy for their pelvic floor outside of the study while enrolled in the study.

\- All patients with the following conditions: severe developmental delay such as CP or wheelchair bound, cannot eat by mouth, mechanical ventilation dependence, etc.

* Nonverbal or unable to effectively communicate needs and preferences.
* Within the voiding dysfunction group, a diagnosis of a congenital GU anomaly (bladder exstrophy, cloacal anomaly, spina bifida, etc.)
* No initial medication usage will be excluded; however, if the patient begins a new medication or treatment regimen during the study, the patient will be excluded.

Where it's running

• University of Colorado Anschutz
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Kelly Harris, MD — University of Colorado, Denver
• Study coordinator: Kelly Harris, MD
• Email: kelly.harris2@childrenscolorado.org
• Phone: (720)777-3926

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.