NCT05688644
Enrolling by Invitation
N/A
Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients
Omri Schwarztuch Gildor1 site in 1 country100 target enrollmentDecember 19, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neurogenic Bladder
- Sponsor
- Omri Schwarztuch Gildor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Decrease of at least 50% in number of catheterizations per day
- Status
- Enrolling by Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
Omri Schwarztuch Gildor
Urologist
Clalit Health Services
Eligibility Criteria
Inclusion Criteria
- •Patients who underwent InterStim II advanced evaluation for approved indication
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Decrease of at least 50% in number of catheterizations per day
Time Frame: 1 year
Decrease of at least 50% in number of fecal incontinence episodes
Time Frame: 1 year
Decrease of at least 50% in number of urge urinary incontinence episodes
Time Frame: 1 year
Secondary Outcomes
- Number of revision surgeries(1 year)
- number of follow-up visits for programming and/or troubleshooting(1 year)
Study Sites (1)
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