Status:
NOT_YET_RECRUITING
HOme PElvic Floor Improvement Trainer Trial
Lead Sponsor:
University of Colorado, Denver
Conditions:
Pelvic Pain
Pelvic Floor Dysfunction
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief 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 trea...
Detailed Description
This study aims to determine if a special device can help children with pelvic floor problems. The pelvic floor issues under investigation include difficulty controlling urination and ongoing pain in ...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06909539
Start Date
June 1 2025
End Date
January 1 2027
Last Update
April 24 2025
Active Locations (1)
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1
University of Colorado Anschutz
Aurora, Colorado, United States, 80011