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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.
This study will be a prospective randomized study comparing bilateral to unilateral sacral neuromodulation. The study population will include all patients diagnosed with interstitial cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at Hahnemann University Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Unilateral Placement of Interstim IPG |
|
| 2 | Active Comparator | Bilateral Placement of Interstim IPG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interstim | Device | Unilateral vs. Bilateral Placement of Interstim IPG |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine if bilateral sacral neuromodulation will reduce the patient's score on the Interstitial Cystitis Symptom and Problem Questionnaire by at least 25% when compared to unilateral sacral neuromodulation in patients with interstitial cystitis. | Post-op, at 6 weeks and at 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if bilateral sacral neuromodulation will improve the patient's voiding diary defined as reduction in urinary frequency by 25% from baseline when compared to unilateral sacral neuromodulation in patients with interstitial cystitis | Post-op, at 6 weeks and 3 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristene E. Whitmore, M.D. | Drexel University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pelvic and Sexual Health Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2017 | |
| Reset | May 19, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2017 | May 19, 2017 |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |