HOme PElvic Floor Improvement Trainer Trial
Starting soon · Not applicable
Conditions studied: Pelvic Pain, Pelvic Floor Dysfunction, Voiding Dysfunction
In brief
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.
Key facts
- Study ID
- NCT06909539
- Run by
- University of Colorado, Denver
- People needed
- 150
- Starts
- 2025-06-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-04-24
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University of Colorado Anschutz — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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