Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
EARLY_PHASE1
Total Enrollment
74 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Study Completion Date
2017-04-27
Brief Summary
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The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment.
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Detailed Description
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The prevalence of benign prostate hyperplasia, like medical illness such as hypertension, diabetes mellitus and stroke, increase by age. Benign prostate hyperplasia will cause bothersome lower urinary tract symptoms in the middle and aged male. Previous studies have showed that overactive bladder syndrome (urge, frequency, nocturia or urinary incontinence) has been considered as an important factor to predict successful treatment.
Urine nerve growth factor level, brain-derived neurotrophic factor and endothelium vascular growth factor have been proved as a simple and noninvasive biomarker for diagnosing overactive bladder. As a result, investigator will investigate the changes of these growth factors level in patients with benign prostate hyperplasia before and after three and six-months medical treatment. In addition, investigator can understand whether overactive bladder will have effects on successful medical treatment in patients with benign prostate hyperplasia.
Urine nerve growth factor level, brain-derived neurotrophic factor and endothelium vascular growth factor have been proved as a simple and noninvasive biomarker for diagnosing overactive bladder. As a result, investigator will investigate the changes of these growth factors level in patients with benign prostate hyperplasia before and after three and six-months medical treatment. In addition, investigator can understand whether overactive bladder will have effects on successful medical treatment in patients with benign prostate hyperplasia.
Conditions
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Benign Prostatic Hyperplasia
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SCREENING
Blinding Strategy
NONE
Study Groups
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urine growth factor
Previous studies have showed that overactive bladder syndrome (urge, frequency, nocturia or urinary incontinence) has been considered as an important factor to predict successful treatment.
Urine nerve growth factor level, brain-derived neurotrophic factor and endothelium vascular growth factor have been proved as a simple and noninvasive biomarker for diagnosing overactive bladder.
Group Type
OTHER
Silodosin
Intervention Type
DRUG
Indications:Benign prostate hyperplasia
Interventions
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Silodosin
Indications:Benign prostate hyperplasia
Intervention Type
DRUG
Other Intervention Names
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Tamsulosin HCl
Dutasteride
Doxazosin (methanesulfonate)
Finasteride
Eligibility Criteria
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Inclusion Criteria
* men with age 50\~80 years old
* IPSS\>12
* maximal flowrate 5\~15ml/sec
* prostate size\>20ml
* urine amount\>150ml
* patient/family can sigh the inform concent
* IPSS\>12
* maximal flowrate 5\~15ml/sec
* prostate size\>20ml
* urine amount\>150ml
* patient/family can sigh the inform concent
Exclusion Criteria
* prostate cancer or suspected prostate cancer(PSA\>4ng/ml)
* history of prostate surgery
* free of active urinary tract infection in past 6 months
* patient with any other serious disease considered by investigator not in the condition to enter trials
* history of prostate surgery
* free of active urinary tract infection in past 6 months
* patient with any other serious disease considered by investigator not in the condition to enter trials
Minimum Eligible Age
50 Years
Maximum Eligible Age
80 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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En Chu Kong Hospital
OTHER
Sponsor Role
lead
Responsible Party
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ChungChengWang
Chief of Department of Urology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Cheng Cheng Wang, M.D Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of urology,En Chu Nong Hospital
Locations
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En Chu Kong Hospital
New Taipei City, , Taiwan
Site Status
Countries
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Taiwan
References
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BACKGROUND
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Liu HT, Chancellor MB, Kuo HC. Urinary nerve growth factor levels are elevated in patients with detrusor overactivity and decreased in responders to detrusor botulinum toxin-A injection. Eur Urol. 2009 Oct;56(4):700-6. doi: 10.1016/j.eururo.2008.04.037. Epub 2008 Apr 30.
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Duckett JR, Basu M. The predictive value of preoperative pressure-flow studies in the resolution of detrusor overactivity and overactive bladder after tension-free vaginal tape insertion. BJU Int. 2007 Jun;99(6):1439-42. doi: 10.1111/j.1464-410X.2007.06842.x. Epub 2007 Apr 5.
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Liu HT, Chancellor MB, Kuo HC. Urinary nerve growth factor level could be a biomarker in the differential diagnosis of mixed urinary incontinence in women. BJU Int. 2008 Nov;102(10):1440-4. doi: 10.1111/j.1464-410X.2008.07757.x. Epub 2008 May 16.
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Liu HT, Chancellor MB, Kuo HC. Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladder. BJU Int. 2009 Jun;103(12):1668-72. doi: 10.1111/j.1464-410X.2009.08380.x. Epub 2009 Feb 11.
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Other Identifiers
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ECKIRB1020407
Identifier Type: -
Identifier Source: org_study_id
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