HOme PElvic Floor Improvement Trainer Trial

Study acronym: HoPe FIT
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 10 months later Jan 1, 2027 → Nov 1, 2028
See other at-risk trials from University of Colorado, Denver

Record History

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  1. Primary and study completion pushed from Jan 1, 2027 to Nov 1, 2028 Show 7 more changesShow less
    • Recruitment opened
    • Start date: Jun 1, 2025 to Nov 1, 2026
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Primary endpoints revised (2)
    • Site details revised
    • Publications: details revised at 4 of 4 entries
  2. Start date: Apr 1, 2025 to Jun 1, 2025
    • Secondary endpoints: details revised at 2 of 2 entries
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06909539
Lead Sponsor University of Colorado, Denver
Conditions
(from sponsor)		 Pelvic Pain, Pelvic Floor Dysfunction, Voiding Dysfunction
Related terms Pelvic Pain
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov