Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

A single center, pilot trial using tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3 months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported outcomes through questionnaires.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital System; Timothy Boone, MD, PhD
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Mitogens; Solifenacin Succinate; Tamsulosin

Criteria

Inclusion Criteria:

• Men > 45 years old with symptomatic LUTS (clinical benign prostatic hypertrophy/BPH)

• International Prostate Symptom Score (IPSS) > 8

• PSA < 10 ng/ml (negative biopsies within 6 months for any age-specific PSA elevation suspicious for prostate carcinoma)

• Post void residual urine < 150 mls

• Urinary Flow rate > 15 mL/sec

Exclusion Criteria:

• Neurogenic bladder

• Urinary tract infection, Urinary stone(s), Urinary tract tumor

• Radiation therapy for urologic malignancy or prostate surgery; radiation to pelvic, colon, rectum, prostate, bladder, uterus or ovaries

• Alpha blocker therapy or anticholinergic therapy within 3 months of entry or 5 alpha reductase therapy within 18 months.

• History of cataracts with planned surgery