The Changes of Urine Growth Factors Level

Early Phase 1

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Silodosin

• Registration Number: NCT06282731
• Lead Sponsor: En Chu Kong Hospital

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.

Study Timeline

• Study Start: 2013-05-31
• Primary Completion: 2016-09-01
• Study Completion: 2017-04-27
• Study First Submitted: 2019-02-11
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
urine growth factor	Silodosin	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.

Primary Outcome Measures

Name	Time	Method
Urine growth factors level	One month after medical treatment	Check Urine growth factors level after one month

Secondary Outcome Measures

Name	Time	Method
Urine growth factors level	Three months after medical treatment	Check Urine growth factors level afterthree month

Trial Locations

Locations (1)

En Chu Kong Hospital; 🇨🇳 New Taipei City, Taiwan