HOme PElvic Floor Improvement Trainer Trial

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06909539
Status
Not Yet Recruiting

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Conditions

  • Pelvic Floor Dysfunction
  • Pelvic Pain
  • Voiding Dysfunction

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Home Pelvic Floor Trainer — DEVICE
    The intervention utilizes a perineometer device with biofeedback features. This device employs external electrodes to measure pelvic floor muscle strength. It then provides real-time feedback through a smartphone application during exercise sessions. The application uses gamification to engage users and track progress. Patients can choose between two games: a bird game or a space-themed game. In the bird game, patients activate their pelvic floor muscles to make the bird fly upward. In the space game, pelvic floor contractions fire a laser or activate a shield. A visual bar displays the strength of pelvic floor contractions. Games are designed to be played for 5 minutes daily, 7 days a week, with increasing difficulty as the user progresses through levels.

Study Details

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 Dates

Start date
Jun 1, 2025
Status verified
Apr 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Voiding Dysfunction
    Patients with voiding dysfunction only and no pelvic pain symptoms will use the home pelvic floor trainer daily for 2 months.
  • Experimental: Pelvic pain
    Patients with pelvic pain with or without voiding dysfunction symptoms will use the home pelvic floor trainer daily for 2 months.

Primary Outcome Measure

Dysfunctional Voiding symptom scale (30 point scale) [ Time Frame: 0 weeks baseline, 4 weeks, and 8 weeks patients will take the DVSS survey ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado AnschutzAuroraColorado80011
Kelly Harris, MD
[email protected]
720-777-3926

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By research site
University of Colorado Anschutz· Aurora, CO

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