Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome (IComaliz)

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

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Intervention / Treatment: Drug: omalizumab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Divisione Urologia IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients 18 years, with a range in body weight of 20 and 150 kg, who have provided written informed consent
• In patients diagnosed with IC/PBS that underwent treatment, basal levels of total serum IgE were 30 and 700 IU/ml and patients showed a positive allergic anamnesis (asthma, rhinitis, atopic dermatitis, etc.)
• Diagnosis of IC/PBS was performed according to the criteria established by the National Institute of Health Consensus Conference and patients had symptoms for at least 3 months. Cytoscopy was performed according to the clinical indications

Exclusion Criteria:

• Pregnancy, breastfeeding. Fertile women that did not use secure contraceptive methods (hormonal or double barrier method). Hysterectomized or surgically sterilized women (tubal ligation) and menopause women were admitted into the study.
• Clinically relevant medical conditions (neoplasia, infections, hematologic, renal, hepatic, cardiovascular, hormonal or gastrointestinal pathologies) within 3 months prior to the study. Other specific criteria included patients with positive anamnesis for bladder cancer or affected by actinic cystitis, vaginitis, symptomatic bladder or urethral diverticulum, active genital herpes, bladder or urethral lithiasis.
• Urination frequency less than 5 times per day.
• Known hypersensitivity to any omalizumab component, excipients included (such as monoclonal antibodies, polyclonal gamma globulins)
• Alcohol or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: treatment with omalizumab; 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

Drug: omalizumab; 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.; Other Names: Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue score (VAS) for pain and urgency- frequency	subjective measurement of pain and urgency	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PUF questionnaire	assessment of bladder pain and urinary frequency	12 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Daniele Porru, MD, Divisione Urologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 14, 2011
• Last Update Submitted That Met QC Criteria: February 11, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: omalizumab; anti-IgE treatment; interstitial cystitis/bladder pain syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Disease; Syndrome; Cystitis; Pain; Cystitis, Interstitial; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: omalizumab-ic