Benign Prostatic Hyperplasia and Glycosaminoglycan

May 20, 2019 updated by: Cagri Akin Sekerci, Marmara University

The Relationship of Lower Urinary System Symptoms Due to Benign Prostatic Hyperplasia and Urinary Glycosaminoglycan Level

Lower urinary tract symptoms (LUTS) are one of the most common conditions in the urology clinic, affecting at least one in four men after 40 years of age. Benign prostatic hyperplasia is the most common cause of LUTS. Bladder dysfunction (hypersensitivity or detrusor overactivity) and bladder outlet obstruction are two main pathologies involved in the etiology of LUTS. In men aged 40-49, moderate and severe LUTS are reported as 26%, while this ratio is doubled in the age group of 70 years and older. Clinically, BPH is defined as an international symptom score of more than 8, a prostate volume of more than 30 ml, and a maximum flow rate of less than 15 ml / sec. Alpha blockers are recommended as the first-line medical treatment according to European Urology Guidelines (EAU Guidelines 2018) for patients diagnosed with BPH clinically. In recent years, many studies have been published on the relationship of urinary biomarkers with LUTS. Nerve growth factor and brain derived neurotrophic factor have been shown to be closely related to neurogenic or non-neurogenic detrusor overactivity and significant improvements were observed after treatment.The relationship between urinary glycosaminoglycan and overactive bladder has been shown and it has been reported that the values have decreased after treatment.Male patients with LUTS caused by BPH often have symptoms of overactive bladder. However, as far as we know, there is no study in the literature about the meaning of urinary GAG levels in this patient group. The aim of this study was to investigate the relationship between urinary glycosaminoglycan levels and patients who had benign prostatic hyperplasia with and without overactive bladder symptoms.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

35 patients and 10 controls were planned to be included in the study. Urine will be collected from patients before and after one month of medical treatment (alpha-blocker). After being centrifuged at 5000 g for 10 minutes, urine will be stored at -80 ° C. At the end of the study, urinary glycosaminoglycan levels will be studied by spectrophotometric method. Urine GAG levels and pre and post treatment uroflowmetry, IPSS, overactive bladder symptom score, bladder frequency volume chart, post void residual urine volume will be compared.

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Recruiting
        • Marmara University
        • Contact:
        • Principal Investigator:
          • Hasan Riza Aydin, Assoc. Prof.
        • Principal Investigator:
          • Yiloren Tanidir, Assoc. Prof.
        • Principal Investigator:
          • Banu Isbilen Basok, Assoc. Prof.
        • Sub-Investigator:
          • Ahmet Ozgur Guctas, MD
        • Sub-Investigator:
          • Hamit Zafer Aksoy, Ass. Prof.
        • Sub-Investigator:
          • Huseyin Kocakgol, MD
        • Sub-Investigator:
          • Firat Akdeniz, MD
        • Sub-Investigator:
          • Mehmet Akif Ramazanoglu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients who had benign prostatic hyperplasia with and without overactive bladder symptoms.

Description

Eligibility Criteria

  1. Male patients presenting with lower urinary tract symptoms to urology outpatient clinic

  2. According to the European Association of Urology Guidelines:

    1. International prostate symptom score> 8
    2. Prostate volume> 40 ml
    3. Q max <15 ml /sn
  3. Patients who did not receive any treatment for lower urinary tract symptoms and applied for the first time
  4. Patients who have not undergone lower urinary tract surgery

Exclusion Criteria

  1. Patients who had undergone medical and surgical treatment for lower urinary tract symptoms
  2. Patients with accompanying urethral stricture
  3. Patients with neurological diseases (Parkinson's, Multiple Sclerosis etc ...)
  4. Patients with spinal cord trauma
  5. Patients with indication for surgical treatment at the time of initial admission (Macroscopic hematuria, bladder stone, urinary retention, upper urinary tract dilatation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who had benign prostatic hyperplasia

Male patients presenting with lower urinary tract symptoms to urology outpatient clinic

According to the European Association of Urology Guidelines:

International prostate symptom score> 8 Prostate volume> 40 ml Q max <15 ml /sn Patients who did not receive any treatment for lower urinary tract symptoms and applied for the first time Patients who have not undergone lower urinary tract surgery
Diagnostic test: Urinary Glycosaminoglycan
Urine will be collected from patients before and after one month of medical treatment (alpha-blocker). After being centrifuged at 5000 g for 10 minutes, urine will be stored at -80 ° C. At the end of the study, urinary glycosaminoglycan levels will be studied by spectrophotometric method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The value of glycosaminoglycan in predicting the success of medical treatment of benign prostatic hyperplasia
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (ACTUAL)

May 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR.UAD.005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Hyperplasia

Clinical Trials on Urinary Glycosaminoglycan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe