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.
FitzGerald, M P; Payne, C K; Lukacz, E S et al. (2012) Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol 187:2113-8 |
Yang, Claire C; Burks, David A; Propert, Kathleen J et al. (2011) Early termination of a trial of mycophenolate mofetil for treatment of interstitial cystitis/painful bladder syndrome: lessons learned. J Urol 185:901-6 |
Foster Jr, Harris E; Hanno, Philip M; Nickel, J Curtis et al. (2010) Effect of amitriptyline on symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. J Urol 183:1853-8 |