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Reduced-dose Botox for Urgency Incontinence Among Elder Females

Study acronym: RELIEF
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 3, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v11
  2. Site details revised at 1 of 7 sitesv10
  3. Study sites: 6 to 7
    • Study description expanded, about 9 words
    • Collaborators: 9 to 10
    v9
  4. Secondary endpoints: details revised at 1 of 10 entries
    • Site details revised at 3 of 6 sites
    • Eligibility criteria expanded, about 2 words
    v8
  5. Site contacts updated at 5 of 6 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date changed from estimate of May 1, 2023 to May 12, 2023v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date: Apr 15, 2023 to May 1, 2023
    v5
  3. Start date: Jan 15, 2023 to Apr 15, 2023
    • Enrollment target: 350 to 376
    v4
  4. Start date: Oct 1, 2022 to Jan 15, 2023
    • Eligibility criteria expanded, about 186 words
    • Secondary endpoints: 11 to 10
    • Study description shortened, about 2 words
    v3
  5. Study description expanded, about 1 word
    • Study title shortened, about 5 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to study the treatment of urgency urinary incontinence (UUI), specifically among women 70 years and older, by comparing reduced versus standard dose of onabotulinumtoxinA (BTX; trade name BOTOX(c)) injection in the bladder.
Trial Details
NCT Number NCT05512039
Lead Sponsor Dartmouth-Hitchcock Medical Center
Collaborators: Patient-Centered Outcomes Research Institute, Dartmouth College, University of Alabama at Birmingham, University of Pittsburgh, University of Texas, Kaiser Permanente, Oregon Health and Science University, Stanford University, University of Connecticut, University of Nebraska
Conditions
(from sponsor)		 Overactive Bladder, Urinary Incontinence in Old Age, Urgency Urinary Incontinence
Related terms Urinary Bladder, Overactive, Urinary Incontinence
Enrollment 376 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov