The Changes of Urine Growth Factors Level

En Chu Kong Hospital

Status and phase: Completed; Early Phase 1

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Silodosin

Study type: Interventional

Funder types: Other

Identifiers

NCT06282731

ECKIRB1020407

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

urine growth factor

Other group

Description:

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.

Treatment:

Drug: Silodosin