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NCT05688644 Clinical Trial

Sacral Neuromodulation in Neurogenic Patients

Overactive Bladder Clinical Trial

Official title:
Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05688644
Other study ID # MMC-0221-21
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 19, 2021
Est. completion date December 31, 2024

Study information
Verified date January 2023
Source Clalit Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who underwent InterStim II advanced evaluation for approved indication Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• InterStim II
Sacral neuromodulation

Locations
Country Name City State
Israel Meir Medical Center Kfar-Sava

Sponsors (1)
Lead Sponsor Collaborator
Omri Schwarztuch Gildor

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease of at least 50% in number of catheterizations per day 1 year
Primary Decrease of at least 50% in number of fecal incontinence episodes 1 year
Primary Decrease of at least 50% in number of urge urinary incontinence episodes 1 year
Secondary Number of revision surgeries 1 year
Secondary number of follow-up visits for programming and/or troubleshooting 1 year
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