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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Mauricio Plata, MD, MSc, FACS
- 電話番号：+57 + 57 3153596900
- メール：invest.urologia@fsfb.org.co
研究場所
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Bogota D.C.
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Bogotá、Bogota D.C.、コロンビア、110111
- Hospital Universitario Fundación Santa Fe de Bogotá
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コンタクト：
- Mauricio Plata, MD, MSc
- 電話番号：3153596900
- メール：invest.urologia@fsfb.org.co
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
Inclusion Criteria:
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Male and female patients aged 18 years or older.
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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.
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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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Urinary Incontinence Severity Assessed by ICIQ-UI SF
時間枠：From pre-implantation to the single follow-up assessment, approximately 6 months to 17 years after implantation.
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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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Global Impression of Improvement (PGI-I)
時間枠：At the single follow-up assessment, approximately 6 months to 17 years after implantation.
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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.
|
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Patient Satisfaction With InterStim
時間枠：At the single follow-up assessment, approximately 6 months to 17 years after implantation.
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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.
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Complete Urinary Continence
時間枠：At the single follow-up assessment, approximately 6 months to 17 years after implantation.
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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.
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Catheter Independence
時間枠：At the single follow-up assessment, approximately 6 months to 17 years after implantation.
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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.
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Incidence of InterStim-Related Complications
時間枠：From implantation through the end of available follow-up, up to approximately 17 years.
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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.
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Time to First Complication
時間枠：From implantation through the end of available follow-up, up to approximately 17 years.
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Time from definitive InterStim implantation to the first documented complication. |
From implantation through the end of available follow-up, up to approximately 17 years.
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Device Replacement or Explantation
時間枠：From implantation through the end of available follow-up, up to approximately 17 years.
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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.
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Therapeutic Failure
時間枠：At the single follow-up assessment and through the end of available follow-up, up to approximately 17 years.
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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.
|
協力者と研究者
協力者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CCEI-19276-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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