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.
Male and female patients aged 18 years or older.
Definitive implantation of the InterStim™ sacral neuromodulation system, performed in one or two stages, at Hospital Universitario Fundación Santa Fe de Bogotá between January 1, 2010, and June 30, 2026.
InterStim™ implantation for at least one of the following conditions:- Overactive bladder.
Urgency urinary incontinence.
History of instrumentation or surgical intervention involving the lumbosacral spine.
Neurogenic lower urinary tract dysfunction.
Patients who underwent the InterStim™ test phase but did not receive definitive implantation of the pulse generator.
Adults with lower urinary tract dysfunction who underwent definitive InterStim™ sacral neuromodulation implantation at Hospital Universitario Fundación Santa Fe de Bogotá between January 1, 2010, and June 30, 2026. The cohort includes patients treated for overactive bladder, urgency urinary incontinence, non-obstructive acontractile detrusor, or non-obstructive urinary retention. All eligible patients identified from institutional records during the study period will be included.
Cohort
Retrospective
InterStim™ Sacral Neuromodulation System II - X
DeviceSacral neuromodulation with the InterStim™ system. Participants included in this observational study previously underwent definitive InterStim implantation as part of their clinical care. The study does not assign or administer the device as a research intervention.
Change in Urinary Incontinence Severity Assessed by ICIQ-UI SF
Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score from the pre-implantation score documented in the medical record to the score obtained at the single follow-up assessment. A reduction of ≥4 points will be considered a clinically meaningful improvement.
Patient Global Impression of Improvement (PGI-I)
Patient-reported improvement in urinary condition assessed using the 7-point Patient Global Impression of Improvement (PGI-I) scale. A favorable response will be defined as "very much better" or "much better."
Patient Satisfaction With InterStim
Overall patient satisfaction with InterStim sacral neuromodulation assessed using a 5-point Likert scale.
Complete Urinary Continence
Proportion of patients with overactive bladder or urgency urinary incontinence who achieve complete urinary continence ("dry") following InterStim implantation.
Catheter Independence
Proportion of patients with non-obstructive urinary retention who achieve independence from intermittent catheterization following InterStim implantation.
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Fundación Santa Fe de Bogota
Lead sponsor
Medtronic
Collaborator
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