The objective is to work in a collaborative effort with other centers of excellence to develop and execute clinical trials for the treatment of interstitial cystitis. Established mechanisms are in place at William Beaumont Hospital, Department of Urology for enrolling and retaining interstitial cystitis patients into clinical research trials. We will work closely with the Interstitial Cystitis Research Network (ICCRN), the Data Coordinating Center, the Steering committee members, and the Urological Chronic Pelvic Pain Syndromes collaborative group to develop clinical research protocols along with ancillary studies on IC.
The specific aims are to determine the role of sacral nerve modulation in treating interstitial cystitis symptoms in established IC patients who have failed traditional medical management or in newly diagnosed IC patients who did not respond to an operative hydro distension and at least 6 months of standard IC therapy. Response rates of sacral nerve modulation in the established IC (> 12 months) and newly diagnosed (<12 months) will be compared. We will use the outcomes criteria already established by the Interstitial Cystitis Clinical Trials Group and in addition, Morphine Dose Equivalents will be monitored before and after permanent implantation of the neuro generator. Adverse events and complications will be monitored. Ancillary studies as agreed upon by the ICCRN will be carried out in conjunction with the clinical trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK065192-01
Application #
6682670
Study Section
Special Emphasis Panel (ZDK1-GRB-1 (M2))
Program Officer
Kusek, John W
Project Start
2003-09-01
Project End
2008-02-28
Budget Start
2003-09-01
Budget End
2004-02-28
Support Year
1
Fiscal Year
2003
Total Cost
$81,483
Indirect Cost
Name
William Beaumont Hospital
Department
Type
DUNS #
076362110
City
Royal Oak
State
MI
Country
United States
Zip Code
48073