A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis

Sant GR, Propert KJ, Hanno PM, Burks D, Culkin D, Diokno AC, Hardy C, Landis JR, Mayer R, Madigan R, Messing EM, Peters K, Theoharides TC, Warren J, Wein AJ, Steers W, Kusek JW, Nyberg LM · The Journal of Urology

The first federally funded, non-industry test of the licensed drug: global response was 34% with PPS versus 18% without (p=0.064), hydroxyzine 31% versus 20% (p=0.26), and no secondary endpoint separated. The authors concluded that neither drug benefited most patients.

Population

121 patients meeting NIH-NIDDK interstitial cystitis criteria with at least moderate pain and frequency

Intervention

Oral PPS and oral hydroxyzine in a 2×2 factorial design

Comparator

The corresponding no-PPS and no-hydroxyzine cells

Limitations

Powered as a feasibility pilot, so a real effect of this size could have been missed; 79% follow-up completeness; bladder endpoints.