Sacral Neuromodulation in Neurogenic Patients

NCT ID: NCT05688644

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-19

Study Completion Date

2024-12-31

Brief Summary

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The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. \[. The main question\[s\] it aims to answer are:

* determine efficacy and safety of the therapy in neurogenic patients.
* compare outcomes of the therapy to idiopathic patients.

If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.

Detailed Description

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Conditions

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Neurogenic Bladder Neurogenic Bowel Urge Incontinence Overactive Bladder Retention, Urinary Fecal Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neurogenic Patients

Patients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II

InterStim II

Intervention Type DEVICE

Sacral neuromodulation

Idiopathic

Patients without underlined relevant neurologic condition, after advanced evaluation of InterStim II

InterStim II

Intervention Type DEVICE

Sacral neuromodulation

Interventions

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InterStim II

Sacral neuromodulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omri Schwarztuch Gildor

OTHER

Sponsor Role lead

Responsible Party

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Omri Schwarztuch Gildor

Urologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MMC-0221-21

Identifier Type: -

Identifier Source: org_study_id

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