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

September 28, 2026 updated by: Mauricio Plata Salazar, Fundación Santa Fe de Bogota

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110111
        • Hospital Universitario Fundación Santa Fe de Bogotá
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  1. Male and female patients aged 18 years or older.

  2. 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.

  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Urinary Incontinence Severity Assessed by ICIQ-UI SF
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Improvement (PGI-I)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Santa Fe de Bogota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCEI-19276-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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