Safety And Efficacy Of The Use Of Intravesical And Oral Pentosan Polysulfate Sodium For Interstitial Cystitis

Main Category: Urology / Nephrology
Also Included In: Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials
Article Date: 17 Feb 2008 - 0:00 PDT

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UroToday.com - Clinical Trial: In an effort to improve treatment results for BPS/IC, Davis and colleagues from Glendora, California and Pittsburgh in a study supported by Ortho-McNeil examined the safety and efficacy of a combination of intravesical and oral pentosan polysulfate sodium (PPS) in the treatment of interstitial cystititis. This randomized, double blind, placebo controlled trial compared 20 patients treated with oral PPS at a dose of 200mg twice daily for 18 weeks with 20 patients who had the same regimen of oral PPS, and intravesical PPS (400mg in 30cc buffered saline) twice weekly during the first six weeks.

At week 18 the proportion of responders (who reported that their overall IC condition improved in comparison to baseline) was comparable in the two groups. The placebo group reported significant reduction in voiding frequency at weeks 6 and 18 compared to the treatment group. The change in the total score of O'Leary-Sant Interstitial Cystitis Symptoms/Problems Index from baseline at week 18 was -12 in the active group and -8 in the placebo group.

The study suggests a statistically significant improvement in patients treated with intravesical PPS. One cannot comment on any effect of the oral medication, as there was no oral placebo arm employed. In addition, all patients in both groups received alkalinized lidocaine prior to intravesical therapy (saline or PPS), which could account for the improvement noted in the placebo group. It is not clear why the oral dose of 200mg BID of PPS was chosen, as this is not the approved dose of medication per the drug label, and no dose response to more than 300mg daily for oral PPS in the treatment of IC has been shown, while side effects are dose dependent1.

This is an interesting paper suggesting that intravesical glycosaminoglycan therapy may be effective in some patients. No conclusions about combined oral and intravesical therapy can be derived from the data as a result of the study design.

Davis EL, El Khoudary SR, Talbott EO, Davis J, Regan LJ

Journal of Urology, 179:177-185, 2008

Reported by UroToday.com Contributing Editor Philip M. Hanno, MD, MPH

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