Ignite Creation Date:
2024-05-05 @ 11:55 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01457573
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2011-10-20
Brief Title:
Pilot Trial Of Urinary Nerve Growth Factor NGF As Biomarker for Male Lower Urinary Tract Symptoms
Sponsor:
Timothy Boone MD PhD
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms A Pilot Trial
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUTS
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 NGFCR 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 pgmL urine creatinine mgdL NGFCr ratio and patient reported questionnaire outcomes AUA Symptom ScoreIPSS 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 04 mg 1 tab and Solifenacin 5 mg 1 tab orally at the same time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 0711-0124 | OTHER | HMRI IRB | None |