A prospective double-blind clinically controlled multicenter trial of sodium pentosanpolysulfate in the treatment of interstitial cystitis and related painful bladder disease

Holm-Bentzen M, Jacobsen F, Nerstrøm B, Lose G, Kristensen JK, Pedersen RH, Krarup T, Feggetter J, Bates P, Barnard R · The Journal of Urology

The first multicentre placebo-controlled trial in the indication PPS is now licensed for, and it was null: no difference from placebo in symptoms, urodynamics, cystoscopic appearance or mast-cell counts in either protocol. The one significant finding was an increase in cystoscopically measured bladder capacity in the verified-interstitial-cystitis arm.

Population

115 patients with painful bladder disease, split into a mast-cell-verified interstitial cystitis protocol (n=43) and an unspecific-histology protocol (n=72)

Intervention

Oral sodium pentosan polysulfate 200 mg twice daily for 4 months

Comparator

Placebo capsules

Limitations

1987 diagnostic criteria and symptom grading; four months of treatment, shorter than the year-plus courses typical in practice; bladder endpoints throughout.