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

Timothy Boone, MD, PhD

Status and phase

Completed

Phase 4

Conditions

Lower Urinary Tract Symptoms

Treatments

Drug: Solifenacin

Drug: Tamsulosin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01457573

IRB# 0711-0124 (Other Identifier)

Pro00006253

Details and patient eligibility

About

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.

Full description

Single center, pilot trial, single arm study using once daily dosing of tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Assessments occur at Baseline, 1 Month, 2 Month and 3 Month to evaluate: urinary NGF (pg/mL), urine creatinine (mg/dL), NGF/Cr ratio and patient reported questionnaire outcomes (AUA Symptom Score/IPSS, Patient Perception of Bladder Condition, Patient Perception of Urge Intensity 'PPIUS', LUTS Urinary Symptoms and Quality of Life). Each participant is assessed from baseline to Month 3 measurements. Protection of human subjects will be provided through the Houston Methodist Research Institute Institutional Review Board (see appendix 2). All men will receive morning dosing with Tamsulosin 0.4 mg (1 tab) and Solifenacin 5 mg (1 tab) orally at the same time.

Enrollment

10 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

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