Sacral Neuromodulation in Neurogenic Patients

• Conditions: Neurogenic Bladder; Neurogenic Bowel; Urge Incontinence; Overactive Bladder; Fecal Incontinence; Retention, Urinary

• Registration Number: NCT05688644
• Lead Sponsor: Omri Schwarztuch Gildor

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-19
• Status Verified: 2023-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Last Update Submitted: 2023-01-09
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease of at least 50% in number of catheterizations per day	1 year
Decrease of at least 50% in number of fecal incontinence episodes	1 year
Decrease of at least 50% in number of urge urinary incontinence episodes	1 year

Secondary Outcome Measures

Name	Time	Method
Number of revision surgeries	1 year
number of follow-up visits for programming and/or troubleshooting	1 year

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar-Sava, Israel