Clinical trial NCT01457573: Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms
Official title: Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2011-10-24
Enrollment: 10
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12
timeFrame: Change from baseline to week 12 (3 months)
measure: Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)
timeFrame: change from baseline score to Month 3
Secondary outcomes:
measure: Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
timeFrame: Change from baseline to months 1, 2 and 3
measure: Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
timeFrame: Change from baseline to months 1, 2 and 3
measure: Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.
timeFrame: Change from baseline to months 1, 2 and 3
measure: Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
timeFrame: Change from baseline to months 1, 2 and 3
measure: Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
timeFrame: Change from baseline to months 1, 2 and 3
measure: Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
timeFrame: Change from baseline to months 1, 2 and 3
measure: Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
timeFrame: Change from baseline to months 1, 2 and 3
measure: Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8
timeFrame: Change from baseline to Mo.1/Wk4 and Mo.2/Wk8
measure: Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.
timeFrame: change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Methodist Hospital System
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Timothy Boone, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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