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Recruiting NCT06909539

HOme PElvic Floor Improvement Trainer Trial

Conditions: Pelvic Pain, Pelvic Floor Dysfunction, Voiding Dysfunction

Sex: All
Ages: 8 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: University of Colorado, Denver

Location: University of Colorado Anschutz Aurora Colorado

Summary

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06909539). StuddyBuddy aggregates publicly available trial information.