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BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Oct 2027 to Oct 2028
    • Site contact updated
    v16
  2. Minor 2 versions Re-verified since Oct 22, 2025, no change to tracked fieldsv14-v15
  3. Minor Study site revisedv13
  4. Notable Primary completion date: Oct 2026 to Oct 2027
    • Study completion date: Dec 2027 to Dec 2028
    • Eligibility criteria revised
    v12
  5. Minor Site contact updatedv11
Show 9 earlier versionsHide 9 earlier versions
  1. Notable Primary completion date: Oct 2025 to Oct 2026
    • Study completion date: Dec 2026 to Dec 2027
    v10
  2. Notable Primary completion date: Oct 2023 to Oct 2025
    • Study completion date: Oct 2024 to Dec 2026
    • Eligibility criteria expanded, about 4 words
    v9
  3. Minor Re-verified, no change to tracked fieldsv8
  4. Notable Primary completion date: Oct 2022 to Oct 2023
    • Study completion date: Oct 2023 to Oct 2024
    v7
  5. Notable Primary completion date: Oct 2021 to Oct 2022
    • Study completion date: Oct 2022 to Oct 2023
    v6
  6. Minor Site contact updatedv5
  7. Minor Start date changed from estimate of Dec 2019 to Dec 18, 2019v4
  8. Minor Start date: Nov 2019 to Dec 2019v3
  9. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2019 to Nov 2019
    • Site details revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.
Trial Details
NCT Number NCT04133675
Lead Sponsor Corewell Health East
Conditions
(from sponsor)
Stress Urinary Incontinence
Related terms Urinary Incontinence, Urinary Incontinence, Stress
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov