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Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms (LUTS)
This study has been completed.
Sponsor:
The Methodist Hospital System
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01457573
First received: October 20, 2011
Last updated: July 16, 2014
Last verified: July 2014
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Purpose
A single center, pilot trial with combination therapy of tamsulosin and solifenacin in 20 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.
| Condition | Intervention |
|---|---|
| Lower Urinary Tract Symptoms | Drug: Solifenacin (Vesicare) 5 mg orally at the same time. |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial |
Resource links provided by NLM:
Further study details as provided by The Methodist Hospital System:
Primary Outcome Measures:
- NGF and NGF/Cr ratio-change [ Time Frame: From baseline to week 12 (3 months) ]Urinary Nerve Growth Factor (NGF) and NGF/Cr ratio-change from baseline to week 12.
Secondary Outcome Measures:
- Quality of Life Questionnaires [ Time Frame: Baseline to weeks 4 and 8. ]International Prostate Symptom Score, Patient Perception of Urgency Score (PPIUS), Perception of Bladder Condition (PBC), International Consultation on Incontinence Modular Questionnaire for male LUTS (ICIQ-MLUTS) and the International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life (ICIQ-LUTSqol).
| Enrollment: | 20 |
| Study Start Date: | October 2011 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tamsulosin 0.4 mg + Solifenacin 5 mg
All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.
|
Drug: Solifenacin (Vesicare) 5 mg orally at the same time.
Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time. |
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men > 50 years old with symptomatic LUTS (clinical BPH)
- IPSS > 8
- PSA < 10 (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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01457573
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457573
Locations
| United States, Texas | |
| The Methodist Hospital System | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
The Methodist Hospital System
Astellas Pharma US, Inc.
Investigators
| Principal Investigator: | Timothy Boone, M.D. | The Methodist Hospital System |
More Information
| Responsible Party: | The Methodist Hospital System |
| ClinicalTrials.gov Identifier: | NCT01457573 History of Changes |
| Other Study ID Numbers: |
IRB# 0711-0124 |
| Study First Received: | October 20, 2011 |
| Last Updated: | July 16, 2014 |
Additional relevant MeSH terms:
|
Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Tamsulosin Solifenacin Succinate Mitogens Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on June 23, 2017