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