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| Sponsors and Collaborators: |
Drexel University Philadelphia Urosurgical Associates Medtronic |
| Information provided by: | Drexel University |
| ClinicalTrials.gov Identifier: | NCT00590473 |
Purpose
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.
| Condition | Intervention |
|
Interstitial Cystitis |
Device: Interstim |
| MedlinePlus related topics: | Interstitial Cystitis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Sacral Neuromodulation: Bilateral Placement vs. Unilateral Placement in Patients With Interstitial Cystitis |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
Unilateral Placement of Interstim IPG
|
Device: Interstim
Unilateral vs. Bilateral Placement of Interstim IPG
|
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2: Active Comparator
Bilateral Placement of Interstim IPG
|
Device: Interstim
Unilateral vs. Bilateral Placement of Interstim IPG
|
Eligibility
| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sandra L. Mosiniak | 267-479-2397 | smosiniak@yahoo.com |
| United States, Pennsylvania | |||||
| Pelvic and Sexual Health Institute | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Principal Investigator: Kristene E. Whitmore, M.D. | |||||
| Drexel University |
| Philadelphia Urosurgical Associates |
| Medtronic |
| Principal Investigator: | Kristene E. Whitmore, M.D. | Drexel University College of Medicine |
More Information
| Responsible Party: | Philadelphia Urosurgical Associates ( Kristene E. Whitmore, M.D./President ) |
| Study ID Numbers: | 71692 |
| First Received: | December 26, 2007 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00590473 |
| Health Authority: | United States: Food and Drug Administration |
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