|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Sacral Neuromodulation in Patients With IC | ||||
| Official Title † | Sacral Neuromodulation: Bilateral Placement vs. Unilateral Placement in Patients With Interstitial Cystitis | ||||
| Brief Summary | 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. |
||||
| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Parallel Assignment | ||||
| Primary Outcome Measure † | 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. [ Time Frame: Post-op, at 6 weeks and at 3 months post-surgery ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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 [ Time Frame: Post-op, at 6 weeks and 3 months post-surgery ] [ Designated as safety issue: No ] | ||||
| Condition † | Interstitial Cystitis | ||||
| Intervention † | Device: Interstim | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 50 | ||||
| Start Date † | April 2007 | ||||
| Completion Date | December 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 79 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
|
||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00590473 | ||||
| Organization ID | 71692 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Drexel University | ||||
| Collaborators †† | Philadelphia Urosurgical Associates Medtronic |
||||
| Investigators † |
|
||||
| Information Provided By | Drexel University | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | December 26, 2007 | ||||
| Last Updated Date | December 26, 2007 | ||||