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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:
If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurogenic Patients | Patients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II |
| |
| Idiopathic | Patients without underlined relevant neurologic condition, after advanced evaluation of InterStim II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterStim II | Device | Sacral neuromodulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of revision surgeries | 1 year | |
| number of follow-up visits for programming and/or troubleshooting | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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patients with approved indication for sacral neuromodulation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D055496 | Neurogenic Bowel |
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| D016055 | Urinary Retention |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012002 | Rectal Diseases |