Pentosan polysulfate sodium for therapy of interstitial cystitis. A double-blind placebo-controlled clinical study

Mulholland SG, Hanno P, Parsons CL, Sant GR, Staskin DR · Urology

One of the two trials the US approval rests on: 28% of PPS patients reported overall improvement greater than 25% versus 13% on placebo, and investigators' global assessments agreed at 26% versus 11%. Pain and urinary pressure favored PPS without reaching significance. Adverse reactions were fewer on PPS than on placebo.

Population

110 patients with interstitial cystitis, US multicentre

Intervention

Oral pentosan polysulfate sodium for 3 months

Comparator

Placebo

Limitations

Responder definition of a 25% global improvement is a low bar; absolute response rates were modest in both arms; bladder endpoints, and the three-month duration is short relative to how the drug is prescribed.