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NOT YET RECRUITING
NCT07856238

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

Sponsor: Fundación Santa Fe de Bogota

View on ClinicalTrials.gov

Summary

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.

Official title: Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for the Management of Lower Urinary Tract Dysfunction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1700

Start Date

2026-12-01

Completion Date

2027-05-30

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DEVICE

InterStim™ Sacral Neuromodulation System II - X

Sacral 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.

Locations (1)

Hospital Universitario Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., Colombia