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Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This observational study will evaluate the long-term effectiveness, safety, and patient satisfaction associated with sacral neuromodulation using the InterStim™ system in adults treated for lower urinary tract dysfunction at Fundación Santa Fe de Bogotá. The study will include patients who underwent definitive InterStim implantation between January 2010 and June 2026 for conditions including overactive bladder, urgency urinary incontinence, non-obstructive acontractile detrusor, or non-obstructive urinary retention. Clinical information before implantation, details of the procedure, complications, reinterventions, device replacements, and explantations will be obtained retrospectively from medical records. Patients who can be contacted will also complete a single telephone follow-up assessment to evaluate current urinary symptoms, perceived improvement, satisfaction with treatment, catheter use, and current device status. The study aims to describe the long-term effectiveness and safety of InterStim therapy in a Colombian population, including changes in urinary incontinence, patient-reported improvement and satisfaction, complications, therapeutic failure, and device survival.
Trial Details
NCT Number NCT07856238
Lead Sponsor Fundación Santa Fe de Bogota
Collaborators: Medtronic
Conditions
(from sponsor)
Overactive Bladder (OAB), Urgency Urinary Incontinence, Non-obstructive Urinary Retention, Non-obstructive Acontractile Detrusor
Related terms Urinary Bladder, Overactive, Urinary Incontinence, Urinary Retention
Enrollment 1,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov