Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Cetirizine; Cromolyn Sodium

Criteria

Inclusion Criteria:

• Male ages 21-80 years old

• Diagnosed with Category III Chronic Pelvic Pain Syndrome

• Patients reporting pain or discomfort in any of the 8 domains of the NIH_ Chronic Prostatitis Symptom Index (NIH-CPSI).

• CP/CPPS symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.

• Mast cell tryptase levels in EPS above a control threshold of 25ng/ml based on healthy men.

Exclusion Criteria:

• Females

• Males <21 and >80 years old

• Patients with a known hypersensitivity to cromolyn sodium or cetirizine hydrochloride

• Patients with impaired renal or hepatic function.

• Mast cell tryptase levels in EPS equal to or below a control threshold of 25ng/ml based on healthy men.