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
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Eligible 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.
Medical 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.
During 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.
Effectiveness 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.
Safety 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.
Follow-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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Mauricio Plata, MD, MSc, FACS
- Puhelinnumero: +57 + 57 3153596900
- Sähköposti: invest.urologia@fsfb.org.co
Opiskelupaikat
-
-
Bogota D.C.
-
Bogotá, Bogota D.C., Kolumbia, 110111
- Hospital Universitario Fundación Santa Fe de Bogotá
-
Ottaa yhteyttä:
- Mauricio Plata, MD, MSc
- Puhelinnumero: 3153596900
- Sähköposti: invest.urologia@fsfb.org.co
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
Inclusion Criteria:
-
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.
Exclusion Criteria:
- 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: RETROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
InterStim Sacral Neuromodulation Cohort
Group/Cohort Description [*] Provide additional information about the group or cohort, including a description of any intervention(s) of interest. |
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Urinary Incontinence Severity Assessed by ICIQ-UI SF
Aikaikkuna: From pre-implantation to the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I)
Aikaikkuna: At the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
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.
|
|
Patient Satisfaction With InterStim
Aikaikkuna: At the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
Overall patient satisfaction with InterStim sacral neuromodulation assessed using a 5-point Likert scale. |
At the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
|
Complete Urinary Continence
Aikaikkuna: At the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
Proportion of patients with overactive bladder or urgency urinary incontinence who achieve complete urinary continence ("dry") following InterStim implantation. |
At the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
|
Catheter Independence
Aikaikkuna: At the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
Proportion of patients with non-obstructive urinary retention who achieve independence from intermittent catheterization following InterStim implantation. |
At the single follow-up assessment, approximately 6 months to 17 years after implantation.
|
|
Incidence of InterStim-Related Complications
Aikaikkuna: From implantation through the end of available follow-up, up to approximately 17 years.
|
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.
|
|
Time to First Complication
Aikaikkuna: From implantation through the end of available follow-up, up to approximately 17 years.
|
Time from definitive InterStim implantation to the first documented complication. |
From implantation through the end of available follow-up, up to approximately 17 years.
|
|
Device Replacement or Explantation
Aikaikkuna: From implantation through the end of available follow-up, up to approximately 17 years.
|
Proportion of patients requiring InterStim device replacement or surgical explantation and the documented reasons for replacement or explantation. |
From implantation through the end of available follow-up, up to approximately 17 years.
|
|
Therapeutic Failure
Aikaikkuna: At the single follow-up assessment and through the end of available follow-up, up to approximately 17 years.
|
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.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Miesten urogenitaaliset sairaudet
- Urologiset sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Virtsaamishäiriöt
- Alempien virtsateiden oireet
- Urologiset ilmenemismuodot
- Virtsarakon sairaudet
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Virtsankarkailu
- Virtsarakko, yliaktiivinen
- Virtsanpidätys
Muut tutkimustunnusnumerot
- CCEI-19276-2026
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .