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HOme PElvic Floor Improvement Trainer Trial
Using a Perineometer Device With Gamification to Improve Symptom Outcomes in Pediatric Pelvic Floor Dysfunction
Who can join
Ages 8 to 18 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Home Pelvic Floor Trainer (device)
Sponsor: University of Colorado, Denver · Participants: 150 · Started: Nov 1, 2026
Contact the study team
- Kelly Harris, MD · Phone: (720)777-3926
Official record on ClinicalTrials.gov — NCT06909539
Locations in the U.S.
| Colorado | University of Colorado Anschutz, Aurora |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.