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

This study has been completed.
Sponsor:
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

October 20, 2011
July 16, 2014
October 2011
July 2014   (final data collection date for primary outcome measure)
NGF and NGF/Cr ratio-change [ Time Frame: From baseline to week 12 (3 months) ] [ Designated as safety issue: Yes ]
Urinary Nerve Growth Factor (NGF) and NGF/Cr ratio-change from baseline to week 12.
Same as current
Complete list of historical versions of study NCT01457573 on ClinicalTrials.gov Archive Site
Quality of Life Questionnaires [ Time Frame: Baseline to weeks 4 and 8. ] [ Designated as safety issue: Yes ]
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).
Same as current
Not Provided
Not Provided
 
Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms
Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lower Urinary Tract Symptoms
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.

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.
Intervention: Drug: Solifenacin (Vesicare) 5 mg orally at the same time.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01457573
IRB# 0711-0124
No
The Methodist Hospital System
The Methodist Hospital System
Astellas Pharma US, Inc.
Principal Investigator: Timothy Boone, M.D. The Methodist Hospital System
The Methodist Hospital System
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP