Safety and efficacy of the use of intravesical and oral pentosan polysulfate sodium for interstitial cystitis: a randomized double-blind clinical trial.
OBJECTIVE
We examined the safety and the efficacy of a combination of intravesical and oral pentosan polysulfate sodium in comparison to only oral pentosan polysulfate sodium in treating interstitial cystitis.


METHODS
A total of 41 females diagnosed with interstitial cystitis were randomized to receive a combination of intravesical pentosan polysulfate sodium plus oral pentosan polysulfate sodium (21 in treatment group) or intravesical placebo plus oral pentosan polysulfate sodium (20 in placebo group) for 6 weeks. All subjects continued to receive oral pentosan polysulfate sodium for another 12 weeks. The primary outcome was the change in the O'Leary-Sant Interstitial Cystitis Symptoms/Problem Index from baseline to week 6, 12, and 18. Other outcomes included: the changes in Pelvic Pain and Urgency Frequency questionnaire, Health Related Quality of Life index: SF-36, pain scale, urgency scale, voiding log, patient global assessment, and sexual function scales.


RESULTS
The change in the total score of O'Leary-Sant Interstitial Cystitis Symptoms/Problems Index from baseline to week 12 among the treatment group (median -12 or approximately a 46% reduction) was significantly greater compared to the placebo group (median -5.5 or approximately a 24% reduction, p = 0.04). At week 18 the treatment group showed statistically significant improvement in all Health Related Quality of Life domains compared to the baseline (p < or = 0.01), while the placebo group showed significant improvement in only 3 Health Related Quality of Life domains, (p < or = 0.05) compared to the baseline. There were no significant differences within major categories of adverse events between treated and placebo groups.


CONCLUSIONS
The use of intravesical pentosan polysulfate sodium simultaneously with oral pentosan polysulfate sodium is a safe and effective therapeutic option. These findings will open a new option for patients with interstitial cystitis to reduce their severely devastating symptoms and to improve their quality of life and well-being.
Davis
Edward L
EL
Citrus Valley Medical Research, Inc., Glendora, California, USA.
El Khoudary
Samar R
SR
Talbott
Evelyn O
EO
Davis
Josephine
J
Regan
Lisa J
LJ
D000283:Administration, Intravesical; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D010426:Pentosan Sulfuric Polyester / Q000008:administration & dosage* / Q000009:adverse effects
D010426:Pentosan Sulfuric Polyester