Clinical trial NCT06282731: The Changes of Urine Growth Factors Level
Official title: The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia After Medical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Benign Prostatic Hyperplasia
Keywords: Benigh Prostate Hyperplasia(BPH)
Urine Growth Factors
Lead sponsor: En Chu Kong Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 74
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment.

Detailed description: 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Urine growth factors level
timeFrame: One month after medical treatment
Secondary outcomes:
measure: Urine growth factors level
timeFrame: Three months after medical treatment
Other outcomes:
measure: Urine growth factors level
timeFrame: Six months after medical treatment
Locations:
city: New Taipei City
country: Taiwan
facility: En Chu Kong Hospital
Study officials:
affiliation: Department of urology,En Chu Nong Hospital
name: Cheng Cheng Wang, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
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