Interstitial Cystitis and Painful Bladder Respond to Intravesical Alkalised Lidocaine: Presented at EAU

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Title: Interstitial Cystitis and Painful Bladder Respond to Intravesical Alkalised Lidocaine: Presented at EAU
URL: http://www.pslgroup.com/dg/21EFD2.htm
Doctor's Guide
April 1, 2008

By Jill Stein

MILAN, Italy -- April 1, 2008 -- Intravesical alkalised lidocaine (PSD597) therapy is showing favourable results when used in the acute treatment of interstitial cystitis/painful bladder syndrome (IC/PBS), investigators reported here at the 23rd Annual European Association of Urology (EAU) Congress.

J. Curtis Nickel, MD, Professor of Urology, Queen's University, Kingston, Ontario, Canada, presented results in 102 adults randomised to daily instillation of intravesical alkalized lidocaine or placebo for 5 days. After a 10-day follow-up period, patients were offered open-label treatment for an additional 5 days and subsequently were followed for another 10 days.

"Local anaesthetics have been administered in the bladder for many years for the treatment of IC/PBS, however none has been able to immediately relieve symptoms without destroying nerve endings or using narcotics," Dr. Nickel said in a presentation on March 28.

When instilled into the bladder, the conversion of local anaesthetic from the ionised, water-soluble form to the lipid-soluble base form may not occur since urine is usually acidic (pH 5-6), leaving most local anaesthetic essentially "ion trapped" within the bladder, he added.

Several small studies, based on the hypothesis that lidocaine would be sufficiently and predictably absorbed by the human bladder if urine pH was buffered to 8, have suggested that alkalised lidocaine has therapeutic potential to treat IC/PBS symptoms, Dr. Nickel explained.

At enrolment, patients in the trial had symptoms of IC/PBS for at least 3 months and pain that exceeded 4 on a 10-point Likert scale.

Patients in the lidocaine and placebo groups had similar baseline demographic and clinical characteristics.

A significantly larger number of patients treated with intravesical alkalised lidocaine reported their overall bladder symptoms as moderately or markedly improved on the Global Response Assessment (GRA) scale on day 8, which was 3 days after treatment was stopped (P = .012).

Overall, 24.0% of patients in the lidocaine group rated their symptoms as moderately or markedly improved on day 15 compared with 11.5% of placebo patients (P = .102). The patient-rated GRA at day 15 was the study's primary endpoint.

When response was analysed across all GRA categories, the difference between treatment with intravesical alkalised lidocaine and placebo at day 15 was significant (65.9% vs 41.7%; P = .005).

Positive results were also seen in all other secondary endpoints with improvements reported in bladder pain, urinary frequency, and urgency, whether assessed as individual symptoms or combined into the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices.

Treatment was safe and well tolerated with none of the systemic side effects that are frequently reported with oral drugs.

IC/PBS is a chronic urological disorder with symptoms of bladder pain, urinary frequency, and urgency without an identifiable cause. The condition affects mostly young and middle-aged women.

Funding for this study was provided by Plethora Solutions.

[Presentation title: Immediate and Sustained Relief From the Symptoms of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) With Intravesical Alkalized Lidocaine (PSD597): Results of a Phase II Multi-Centre, Placebo-Controlled Trial. Abstract 863]

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