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

NCT07856238 | Not Yet Recruiting FDA Device

• 1 other identifier: CCEI-19276-2026
• Study Type: observational
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder (OAB); Urgency Urinary Incontinence; Non-obstructive Urinary Retention; Non-obstructive Acontractile Detrusor

Keywords

Sacral Neuromodulation; InterStim; Lower Urinary Tract Dysfunction; Overactive Bladder; Urinary Incontinence; Urgency Urinary Incontinence; Urinary Retention; Non-obstructive Urinary Retention; Sacral Nerve Stimulation; Device Survival; Patient-reported Outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (8)

• Patient Global Impression of Improvement (PGI-I)

  At the single follow-up assessment, approximately 6 months to 17 years after implantation.

• Patient Satisfaction With InterStim

  At the single follow-up assessment, approximately 6 months to 17 years after implantation.

• Complete Urinary Continence

  At the single follow-up assessment, approximately 6 months to 17 years after implantation.

• Catheter Independence

  At the single follow-up assessment, approximately 6 months to 17 years after implantation.

• Incidence of InterStim-Related Complications

  From implantation through the end of available follow-up, up to approximately 17 years.

Study Arms (1)

InterStim Sacral Neuromodulation Cohort

Group/Cohort Description \[\*\] Provide additional information about the group or cohort, including a description of any intervention(s) of interest.

Device: InterStim™ Sacral Neuromodulation System II - X

Interventions

InterStim™ Sacral Neuromodulation System II - X DEVICE

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.

InterStim Sacral Neuromodulation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Non-obstructive acontractile detrusor.
• Non-obstructive urinary retention.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead
• Medtronic: collaborator

Study Sites (1)

Hospital Universitario Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., 110111, Colombia

Location

Related Publications (12)

• Al-zahrani AA, Elzayat EA, Gajewski JB. Long-term outcome and surgical interventions after sacral neuromodulation implant for lower urinary tract symptoms: 14-year experience at 1 center. J Urol. 2011 Mar;185(3):981-6. doi: 10.1016/j.juro.2010.10.054. Epub 2011 Jan 19.

  PMID: 21247597 BACKGROUND

• Chartier-Kastler E, Le Normand L, Ruffion A, Saussine C, Braguet R, Rabut B, Ragni E, Perrouin-Verbe MA, Pierrevelcin J, Rousseau T, Game X, Tanneau Y, Dargent F, Biardeau X, Graziana JP, Stoica G, Brassart E, Fourmarier M, Yaghi N, Capon G, Ferchaud J, Berrogain N, Peyrat L, Pecoux F, Bryckaert PE, Karsenty G, Song S, Keller DUJ, Cornu JN. Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation. Eur Urol Focus. 2023 Sep;9(5):765-772. doi: 10.1016/j.euf.2023.03.008. Epub 2023 Apr 3.

  PMID: 37019729 BACKGROUND

• Raina S. Neuromodulation for Restoration of Urinary and Bowel Control. Neurol India. 2020 Nov-Dec;68(Supplement):S307-S315. doi: 10.4103/0028-3886.302457.

  PMID: 33318367 BACKGROUND

• Chartier-Kastler E, Le Normand L, Ruffion A, Dargent F, Braguet R, Saussine C, Tanneau Y, Graziana JP, Ragni E, Rabut B, Rousseau T, Biardeau X, Game X, Pierrevelcin J, Brassart E, Fourmarier M, Stoica G, Berrogain N, Yaghi N, Pecoux F, Capon G, Ferchaud J, Peyrat L, Bryckaert PE, Karsenty G, Melotti A, Abouihia A, Keller DUJ, Cornu JN. Sacral Neuromodulation with the InterStim System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study. Eur Urol Focus. 2021 Nov;7(6):1430-1437. doi: 10.1016/j.euf.2020.06.026. Epub 2020 Sep 7.

  PMID: 32907782 BACKGROUND

• Schmidt RA, Senn E, Tanagho EA. Functional evaluation of sacral nerve root integrity. Report of a technique. Urology. 1990 May;35(5):388-92. doi: 10.1016/0090-4295(90)80078-2.

  PMID: 2336766 BACKGROUND

• Van Kerrebroeck PE, Marcelissen TA. Sacral neuromodulation for lower urinary tract dysfunction. World J Urol. 2012 Aug;30(4):445-50. doi: 10.1007/s00345-011-0780-2. Epub 2011 Oct 12.

  PMID: 21989816 BACKGROUND

• Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.

  PMID: 12811491 BACKGROUND

• Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, Hamid R, Karsenty G, Kessler TM, Schneider M, 't Hoen L, Blok B. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016 Feb;69(2):324-33. doi: 10.1016/j.eururo.2015.07.071. Epub 2015 Aug 22.

  PMID: 26304502 BACKGROUND

• Peeters K, Sahai A, De Ridder D, Van Der Aa F. Long-term follow-up of sacral neuromodulation for lower urinary tract dysfunction. BJU Int. 2014 May;113(5):789-94. doi: 10.1111/bju.12571.

  PMID: 24238278 BACKGROUND

• Hussain Z, Harrison SC. Neuromodulation for lower urinary tract dysfunction--an update. ScientificWorldJournal. 2007 Jun 22;7:1036-45. doi: 10.1100/tsw.2007.173.

  PMID: 17619785 BACKGROUND

• Kinsey D, Pretorius S, Glover L, Alexander T. The psychological impact of overactive bladder: A systematic review. J Health Psychol. 2016 Jan;21(1):69-81. doi: 10.1177/1359105314522084. Epub 2014 Mar 2.

  PMID: 24591118 BACKGROUND

• Siegel S, Noblett K, Mangel J, Bennett J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Zylstra S, Kan F, Berg KC. Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation. J Urol. 2018 Jan;199(1):229-236. doi: 10.1016/j.juro.2017.07.010. Epub 2017 Jul 11.

  PMID: 28709886 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Urinary Retention

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Central Study Contacts

Mauricio Plata, MD, MSc, FACS

CONTACT

+ 57 3153596900; invest.urologia@fsfb.org.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Urology

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)