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BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Study acronym: EmsellaOAB
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Primary completion date: Jun 2026 to Jun 2028
    • Study completion date: Dec 2027 to Dec 2028
    v13
  3. Study site revisedv12
  4. Primary completion date: Jun 2025 to Jun 2026
    • Study completion date: Dec 2025 to Dec 2027
    • Site contact updated
    v11
  5. Site contact updatedv10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Jun 2023 to Jun 2025
    • Study completion date: Dec 2024 to Dec 2025
    • Eligibility criteria expanded, about 3 words
    v9
  2. Site contact updatedv8
  3. Site contact updated
    • Eligibility criteria expanded, about 5 words
    v7
  4. Start date changed from estimate of Jan 2022 to Nov 22, 2021v6
  5. Start date: Oct 2021 to Jan 2022v5
  6. Start date: Aug 2021 to Oct 2021v4
  7. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary completion date: Jun 2022 to Jun 2023
    • Start date: Jun 2021 to Aug 2021
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Study completion date: Dec 2022 to Dec 2024
    • Secondary endpoints: details revised at 1 of 7 entries
  8. Interventions: BTL Emsella Chair (Device) to BTL Emsella Chair (Device), Sham BTL Emsella Chair (Device)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.
Trial Details
NCT Number NCT04873037
Lead Sponsor Corewell Health East
Conditions
(from sponsor)		 Overactive Bladder Syndrome, Overactive Bladder, Urinary Frequency, Urinary Urgency
Related terms Urinary Bladder, Overactive
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov