Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction
Condition: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Pelvic Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study is to evaluate inhibition of mast cells and the histamine 1
      receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome
      (CPPS).
    

Detailed description: 
      Chronic pelvic pain is a hallmark of patients with CPPS, a non-bacterial category of
      prostatitis that is a significant source of morbidity in men. The cause of CPPS is unknown
      and there is a lack of biomarkers for diagnosis of this syndrome. Research in animal models
      of CP/CPPS have pointed to a role for mast cells and their degranulation constituents
      including mast cell tryptase in the development of pelvic pain and lower urinary tract
      symptoms. This study aims to evaluate the ability of FDA approved and marketed drugs to
      inhibit the release of mast cell tryptase and to ameliorate symptoms in patients with
      CP/CPPS.

      This is an open label study to evaluate the efficacy of Cromolyn Sodium Oral Solution and
      Cetirizine hydrochloride (tablet) in men with CP/CPPS to reduce mast cell tryptase levels in
      expressed prostatic fluids and to show improvement in symptoms of CP/CPPS. There is no
      control group for the study. The difference between pre- and post-treatment levels across
      individuals will be assessed.

      The study will consist of 3 periods: the Screening Period (Days -7 to -1), the Treatment
      Period (Days 1 to 21), and the Follow-up Period (7 days) after the last dose at Day 21.

      During screening, subjects will be admitted to the clinic, undergo specimen (Expressed
      prostatic secretions (EPS), urine and blood) collection and recording of their baseline
      questionnaire responses Subjects will provide a basic health history, including current
      general health, adverse events, medications or treatments within the past 5 years. A physical
      examination including vital heart rate, breathing rate, blood pressure, temperature, height,
      weight and body mass will be taken. Subsequently, EPS from eligible subjects will be
      collected by the clinical team and assayed for the levels of mast cell tryptase within 24
      hours of sample collection at the screening visit. 20 subjects with elevated mast cell
      tryptase will be identified and will be eligible for receiving the study medication from the
      Investigational pharmacy at Northwestern University.

      Eligible subjects will be required to take medication for days 1-21 (Week 1-3), record their
      symptom scores weekly using the NIH-CPSI, and record all safety related symptoms.

      Subjects will return to the clinic after the completion of three weeks of treatment.
      Expressed prostatic secretions (EPS), blood as well as a voided bladder 1, 2 and 3 (VB1-3)
      urine specimens will be collected as at baseline and after the last dose at day 21 for
      evaluating mast cell tryptase levels. A review subject's general health, adverse events, and
      any medications that have changed since the last visit will be collected. Vital signs (heart
      rate, breathing rate, blood pressure, temperature, weight and BMI will be collected.

      Treated subjects will be contacted by phone 7 days after treatment by the study coordinator
      to follow up on any study related adverse effects or changes in symptoms.
    

Intervention name(s): Cromolyn Sodium; Cetirizine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Mast cell stabilizer; Histamine receptor antagonist
Other intervention name(s): Gastrocrom; Zyrtec
Intervention MeSH terms: Cetirizine; Cromolyn Sodium
Intervention model: Single Group Assignment
Intervention model description: Comparison of mast cell tryptase levels and changes in symptom scores after treatment with cromolyn sodium and cetirizine hydrochloride
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: chronic pain; prostatitis; pelvic pain