Time to Initiation of Pentosan Polysulfate Sodium Treatment After Interstitial Cystitis Diagnosis: Effect on Symptom Improvement

Nickel, J. Curtis; Kaufman, David M.; Zhang, Huabin F.; Wan, George J.; Sand, Peter K.

doi:10.1016/j.urology.2007.09.013

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Volume 71, Issue 1 , Pages 57-61, January 2008

Time to Initiation of Pentosan Polysulfate Sodium Treatment After Interstitial Cystitis Diagnosis: Effect on Symptom Improvement

Presented at the meeting of the American Urologynecologic Society, Palm Springs, Calif, October 19-21, 2006.

J. Curtis Nickel
- Queen’s University, Kingston, Ontario, Canada
- Dr. Nickel is a consultant and has served on the speakers’ bureau for Ortho-McNeil Pharmaceutical, Inc.
- Reprint requests: J. Curtis Nickel, MD, FRCS(C), Queens University Department of Urology, Kingston General Hospital, 76 Stuart Street, Kingston, Ontario, Canada K7L2V7.
David M. Kaufman
- Central Park Urology, New York, New York
- Dr. Kaufman has served on the speakers’ bureau for Ortho-McNeil Pharmaceutical, Inc. and Bayer Pharmaceuticals.
Huabin F. Zhang
- Ortho Women’s Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc, Raritan, New Jersey
George J. Wan
- Ortho Women’s Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc, Raritan, New Jersey
Peter K. Sand
- Evanston Continence Center, Northwestern University, Evanston, Illinois
- Dr. Sand has received research support and has served as a consultant and a member of the speakers’ bureau for Ortho-McNeil Pharmaceutical, Inc.

Received 26 April 2007; accepted 13 September 2007.

Objectives

Interstitial cystitis (IC) is a chronic, debilitating condition that is often associated with late diagnosis and a delay in initiation of appropriate IC-specific therapy. The purpose of this study was to determine whether the length of time from initial diagnosis to start of treatment impacts subsequent symptom improvement.

Methods

A retrospective analysis was conducted in 128 patients with IC who had been treated with pentosan polysulfate sodium (PPS) 300 mg/day for 32 weeks in a multicenter, randomized, double-blind, parallel-group clinical trial. Outcome measures included the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and the O’Leary-Sant Interstitial Cystitis Problem Index (ICPI). Early treatment was defined as treatment initiation 6 months or less after IC diagnosis, whereas late treatment was defined as treatment initiation 24 months or more after IC diagnosis. Efficacy data were analyzed by using the intent-to-treat, last-observation-carried-forward population.

Results

At the end of the study, mean changes from baseline in total ICSI and ICPI scores (± SEM) for early treatment (6 months or less) versus late treatment (24 months or more) were 3.97 ± 0.59 versus 2.15 ± 0.70 (P = 0.0472) and 3.94 ± 0.56 versus 1.77 ± 0.63 (P = 0.0117), respectively. Similar trends for both measures were observed when examining other times from IC diagnosis (3 months or less versus 24 months or more, 3 months or less versus 36 months or more, and 6 months or less versus 36 months or more).

Conclusions

Initiation of PPS treatment within 6 months of establishing the diagnosis of IC may be associated with greater improvement in patient symptoms and symptom bother.