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Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v6
  2. Minor Site contacts updated at 2 of 5 sitesv5
  3. Minor Site details revised at 1 of 5 sitesv4
  4. Minor Site details revised at 5 of 5 sitesv3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence. Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin and/or mirabegron and ready for withdrawal will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving.
Trial Details
NCT Number NCT06465576
Lead Sponsor University of Aarhus
Conditions
(from sponsor)
Urinary Incontinence in Children
Related terms Urinary Incontinence
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov