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NCT Number: NCT06282731

The Changes of Urine Growth Factors Level

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

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Key information

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

En Chu Kong Hospital

New Taipei City, 23702, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silodosin

Drug

Indications:Benign prostate hyperplasia

Other names: Tamsulosin HCl, Dutasteride, Doxazosin (methanesulfonate), Finasteride

Primary outcomes

  1. Urine growth factors level

    Time frame: One month after medical treatment

    Check Urine growth factors level after one month

Secondary outcomes

  1. Urine growth factors level

    Time frame: Three months after medical treatment

    Check Urine growth factors level afterthree month

Other outcomes

  1. Urine growth factors level

    Time frame: Six months after medical treatment

    Check Urine growth factors level after si xmonth

Sponsors and collaborators

Lead sponsor

En Chu Kong Hospital

Other

Registry information

Official study title

The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia After Medical Treatment

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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