HOme PElvic Floor Improvement Trainer Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorUniversity of Colorado, Denver
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Home Pelvic Floor Trainer
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
1University of Colorado Anschutz80011, AuroraColorado, United States
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
Source ClinicalTrials.gov