Treatment options are few for interstitial cystitis patients, especially for those with refractory disease. Frustratingly, trial after trial of promising therapies have shown no real improvement compared with placebo. But yesterday, that changed with presentation of the results of a trial of intravesical alkalinized lidocaine.
Treatment options are few for interstitial cystitis patients, especially for those with refractory disease. Frustratingly,trial after trial of promising therapies have shown no real improvement compared with placebo. But yesterday, that changedwith presentation of the results of a trial of intravesical alkalinized lidocaine.
"This is the first time I have been able to stand up at the podium at AUA and actually been able to present a positive studypowered enough to be able to show the benefit we had hoped to achieve," Curtis Nickel, MD, of Queen's University in Kingston,Ontario, told Urology Times.
There had been a few small clinical trials showing that alkalinization of lidocaine improves absorption into the bladder andthat the therapy decreases pain. But this trial, using a proprietary combination and delivery system (PSD597) is the firstrandomized, placebo-controlled trial that put the therapy to the test. Fifty patients received instillations on 5 consecutivedays, and follow-up was done on days 8 and 15 with a global response assessment as the primary endpoint. Patients alsocompleted the O'Leary-Sant Symptom and Problem Index and rated their bladder pain. Then they had the option to continuetreatment with 5 more days of instillations in an open label extension of the trial.
On day 8, 30% of patients were responders, rating their improvement moderate or marked, compared with only 10% of placebopatients. On day 15, 24% were responders, compared with 12% of placebo patients. O'Leary-Sant scores were also significantlybetter than placebo. Pain scores improved markedly, although the difference with placebo was not statistically significant.Continuing the treatment in the open-label trial increased the response rate to 65%.
Urologists and other physicians can put the results of this study to use in their practice today, although the proprietarycombination is not yet available, said Dr. Nickel. First, they can use generic lidocaine followed by bicarbonate. That's anadvantage over instillations of anesthetic and other medications in an acidic environment that many still use. In addition,the trial results suggest that longer-term therapy may be beneficial, so these instillations may offer significant painrelief, not only for painful flare-ups, but also for chronic treatment, Dr. Nickel said.