Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Mar 1, 2027 → Sep 1, 2027
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Record History

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  1. Primary and study completion pushed from Mar 1, 2027 to Sep 1, 2027 Show 6 more changesShow less
    • Start date: Sep 26, 2023 to Aug 18, 2023
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Collaborators: 1 to 3
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 3 words
  2. Collaborators: 3 to 1v5
  3. Collaborators revised (3)v4
  4. Primary completion date: Jan 1, 2025 to Mar 1, 2027v3 Show 6 more changesShow less
    • Study completion date: Jan 1, 2026 to Mar 1, 2027
    • Start date changed from estimate of Sep 1, 2023 to Sep 26, 2023
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Study description expanded, about 8 words
    • Collaborators expanded, about 9 words
  5. Start date: Jan 1, 2023 to Sep 1, 2023v2
  6. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A multi-center double-blinded placebo-controlled randomized clinical trial. The patients will be randomized into two groups. To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD). After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF. Period of randomization: four months. Number anticipated to be included: 60 patients
Trial Details
NCT Number NCT05380856
Lead Sponsor Odense University Hospital
Collaborators: University of Copenhagen, Aarhus University Hospital, Aalborg University Hospital
Conditions
(from sponsor)		 Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation, Bowel Dysfunction, Sexual Dysfunction, Quality of Life
Related terms Intestinal Diseases, Multiple Sclerosis, Sexual Dysfunction, Physiological, Urinary Bladder, Neurogenic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov