Sacral Neuromodulation in Neurogenic Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Neurogenic Patients Patients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II |
Device: InterStim II
Sacral neuromodulation
|
Idiopathic Patients without underlined relevant neurologic condition, after advanced evaluation of InterStim II |
Device: InterStim II
Sacral neuromodulation
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of revision surgeries [1 year]
- number of follow-up visits for programming and/or troubleshooting [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who underwent InterStim II advanced evaluation for approved indication
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Meir Medical Center | Kfar-Sava | Israel |
Sponsors and Collaborators
- Omri Schwarztuch Gildor
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MMC-0221-21