[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658726":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":45,"studyPopulation":46,"armGroups":47,"interventions":53,"overallOfficials":41,"centralContacts":59,"locations":66,"responsibleParty":84,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":41,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":41,"enrollmentInfo":101,"targetDuration":41,"studyType":104,"phases":41,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":121,"whyStopped":41,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Fundación Santa Fe de Bogota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"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.","From pre-implantation to the single follow-up assessment, approximately 6 months to 17 years after implantation.",[14,18,21,24,27,31,34,37],{"measure":15,"description":16,"timeFrame":17},"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.\"","At the single follow-up assessment, approximately 6 months to 17 years after implantation.",{"measure":19,"description":20,"timeFrame":17},"Patient Satisfaction With InterStim","Overall patient satisfaction with InterStim sacral neuromodulation assessed using a 5-point Likert scale.",{"measure":22,"description":23,"timeFrame":17},"Complete Urinary Continence","Proportion of patients with overactive bladder or urgency urinary incontinence who achieve complete urinary continence (\"dry\") following InterStim implantation.",{"measure":25,"description":26,"timeFrame":17},"Catheter Independence","Proportion of patients with non-obstructive urinary retention who achieve independence from intermittent catheterization following InterStim implantation.",{"measure":28,"description":29,"timeFrame":30},"Incidence of InterStim-Related Complications","Proportion of patients experiencing perioperative or postoperative complications following InterStim implantation. Complications will be classified according to the Clavien-Dindo classification.","From implantation through the end of available follow-up, up to approximately 17 years.",{"measure":32,"description":33,"timeFrame":30},"Time to First Complication","Time from definitive InterStim implantation to the first documented complication.",{"measure":35,"description":36,"timeFrame":30},"Device Replacement or Explantation","Proportion of patients requiring InterStim device replacement or surgical explantation and the documented reasons for replacement or explantation.",{"measure":38,"description":39,"timeFrame":40},"Therapeutic Failure","Proportion of patients meeting the protocol-defined composite therapeutic failure endpoint: device explantation or permanent deactivation due to lack of efficacy; less than a 4-point reduction in ICIQ-UI SF among patients with an available pre-implantation score or PGI-I indicating \"no change\" or worse; or persistent need for intermittent catheterization among patients with non-obstructive urinary retention.","At the single follow-up assessment and through the end of available follow-up, up to approximately 17 years.",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"COHORT","RETROSPECTIVE","This is an observational analytical retrospective cohort study with a single cross-sectional follow-up assessment. The study will include adult patients who underwent definitive implantation of the InterStim™ sacral neuromodulation system at Hospital Universitario Fundación Santa Fe de Bogotá between January 1, 2010, and June 30, 2026, for lower urinary tract dysfunction, including overactive bladder, urgency urinary incontinence, non-obstructive acontractile detrusor, and non-obstructive urinary retention.\n\nEligible patients will be identified consecutively using available institutional sources, including surgical scheduling records, procedure codes, and implantable device records. Data will be obtained from two sources: retrospective review of electronic medical records and a single telephone follow-up assessment.\n\nMedical record review will include sociodemographic and clinical characteristics, indication for sacral neuromodulation, previous treatments, available pre-implantation patient-reported outcome measures, procedural characteristics, perioperative complications, reprogramming, reinterventions, device replacements, explantations, and other events occurring during follow-up.\n\nDuring the single telephone follow-up, contactable patients who agree to participate will complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), the Patient Global Impression of Improvement (PGI-I), and a 5-point Likert satisfaction scale. Current device status, catheter use, and additional urinary medications will also be recorded.\n\nEffectiveness will be assessed using patient-reported urinary outcomes, including change in ICIQ-UI SF score when a pre-implantation score is available, with a reduction of at least 4 points considered clinically meaningful improvement. The PGI-I will provide an assessment of perceived improvement regardless of the availability of a baseline questionnaire. Additional effectiveness outcomes will include complete continence among patients with overactive bladder or urgency urinary incontinence and catheter independence among patients with non-obstructive urinary retention.\n\nSafety outcomes will include perioperative and postoperative complications, classified according to the Clavien-Dindo classification, as well as reinterventions, device replacement, and surgical explantation. Device outcomes will include the frequency and causes of replacement or explantation and replacement- or explant-free device survival at 1, 3, 5, and 10 years.\n\nFollow-up time will vary according to the date of definitive implantation and will extend from the index implantation date to the telephone assessment for patient-reported outcomes, or to the last available medical record information, definitive explantation, or death, as applicable for safety and device-survival outcomes.","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.",[48],{"label":49,"type":41,"description":50,"interventionNames":51},"InterStim Sacral Neuromodulation Cohort","Group\u002FCohort Description \\[\\*\\] Provide additional information about the group or cohort, including a description of any intervention(s) of interest.",[52],"Device: InterStim™ Sacral Neuromodulation System II - X",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":41},"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.",[49],[60],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Mauricio Plata, MD, MSc, FACS","CONTACT","+ 57 3153596900","+57","invest.urologia@fsfb.org.co",[67],{"facility":68,"status":41,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Hospital Universitario Fundación Santa Fe de Bogotá","Bogotá","Bogota D.C.","110111","Colombia","CO",{"type":75,"coordinates":76},"Point",[77,78],-74.08175,4.60971,{"lat":78,"lon":77},[81],{"name":82,"role":62,"phone":83,"phoneExt":41,"email":65},"Mauricio Plata, MD, MSc","3153596900",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Mauricio Plata Salazar","Head of the Department of Urology",[89],{"name":90,"class":91},"Medtronic","INDUSTRY","100658726","long-term-effectiveness-and-safety-of-sacral-neuromodulation-with-interstim-for-lower-urinary-tract-dysfunction-100658726",false,"NCT07856238","Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction","Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for the Management of Lower Urinary Tract Dysfunction","Inclusion Criteria:\n\n1. Male and female patients aged 18 years or older.\n2. 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.\n3. InterStim™ implantation for at least one of the following conditions:- Overactive bladder.\n\n   * Urgency urinary incontinence.\n   * Non-obstructive acontractile detrusor.\n   * Non-obstructive urinary retention.\n\nExclusion Criteria:\n\n* History of instrumentation or surgical intervention involving the lumbosacral spine.\n* Neurogenic lower urinary tract dysfunction.\n* Patients who underwent the InterStim™ test phase but did not receive definitive implantation of the pulse generator.","ALL","18 Years",{"count":102,"type":103},1700,"ESTIMATED","OBSERVATIONAL","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.\n\nClinical 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.\n\nThe 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.",[107,108,109,110],"Overactive Bladder (OAB)","Urgency Urinary Incontinence","Non-obstructive Urinary Retention","Non-obstructive Acontractile Detrusor",[112,113,114,115,116,108,117,109,118,119,120],"Sacral Neuromodulation","InterStim","Lower Urinary Tract Dysfunction","Overactive Bladder","Urinary Incontinence","Urinary Retention","Sacral Nerve Stimulation","Device Survival","Patient-reported Outcomes","NOT_YET_RECRUITING","2026-09-28",{"date":124,"type":125},"2026-10-02","ACTUAL",{"date":127,"type":103},"2026-12-01",{"date":129,"type":103},"2027-05-30",{"name":5,"class":6},1]