HOme PElvic Floor Improvement Trainer Trial

Launched by UNIVERSITY OF COLORADO, DENVER · Mar 27, 2025

Keywords

ClinConnect Summary

The HOme PElvic Floor Improvement Trainer Trial is a study aimed at helping people who experience pelvic pain or issues with bladder control, like needing to go to the bathroom frequently or having accidents. The researchers want to see if a special device that provides biofeedback—essentially helping you understand how your body works—can be an effective treatment option for these conditions. This device could be used at home before or instead of going to physical therapy.

To participate in the trial, you need to be between 8 and 18 years old and have symptoms like pain in the pelvic area or bladder problems. However, if you have recently seen a physical therapist for these issues, you would not be eligible to join. The study is not currently recruiting participants, so you would need to wait until they start. If you join, you can expect to use the device at home and share your experiences with the researchers to help improve treatment for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • - 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.