A quantitatively controlled method to study prospectively interstitial cystitis and demonstrate the efficacy of pentosanpolysulfate

Parsons CL, Benson G, Childs SJ, Hanno P, Sant GR, Webster G · The Journal of Urology

The registration trial behind the 1996 US approval: 32% of PPS patients showed significant global improvement versus 16% on placebo, with significant reductions in pain and urgency and more patients gaining over 20 ml in voided volume. Adverse effects were minor and no more frequent than on placebo.

Population

148 patients with interstitial cystitis across 7 US clinical centres

Intervention

Oral pentosan polysulfate 100 mg three times daily

Comparator

Placebo

Limitations

Patient-reported global assessment as the primary measure; the 300 mg/day dose became the label dose largely on this trial; bladder endpoints throughout.