Interstitial Cystitis Clinical Trial
Official title:
Explorative Study on the Use of Omalizumab in Patients Suffering From Interstitial Cystitis/Painful Bladder Syndrome
By hypothesising that Interstitial Cystitis is an allergic disorder of the urogenital system that is linked to mast-cells, current therapy with omalizumab may represent a potential non symptomatic strategy for the treatment of IC/BPS
Interstitial cystitis/Bladder Pain Syndrome is a chronic inflammatory disease of the
bladder, that is characterized by pain in the pelvic region and a frequent need to urinate.
So far there is not a an effective treatment for this uncommon distressing condition.
The objective of this preliminary study was to evaluate the efficacy of omalizumab in the
treatment of Interstitial Cystitis/Bladder Pain Syndrome, evaluated by visual analogue score
(VAS) for pain and urgency- frequency, O'Leary-Sant IC symptom and problem index
questionnaire (primary outcome), PUF questionnaire and Patient Global Assessment
questionnaire, and urination diary (secondary outcomes).
Three female adult patients (24-34 years) suffering form Interstitial Cystitis and chronic
bladder pain were included in the study. The omalizumab dose has been calculated on the
basis of body weight and basal levels of total serum IgE. Treatment was administered
subcutaneously every 2 or 4 weeks (according to the calculated total dose) for a total of 48
weeks. Each vial contained 150 mg of the active compound, therefore the number of injections
for each administration varied between 1 and 3, depending on the total dose used. Patients
were allowed to take drugs used for IC (Fibrase, Pelvilen, Normast, Quercetin, Chondroitin,
Glucosamine per os). During the screening process, the dosage of these drugs was established
and stably maintained during the 4 week run-in period.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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