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

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ClinicalTrials.gov Identifier: NCT01457573
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Lower Urinary Tract Symptoms Drug: Solifenacin (Vesicare) 5 mg orally at the same time.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2011
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.



Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Mitogens
Tamsulosin
Solifenacin Succinate
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents