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Benign Prostatic Hyperplasia and Glycosaminoglycan

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ClinicalTrials.gov Identifier: NCT03955484
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Cagri Akin Sekerci, Marmara University

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostatic Hyperplasia Diagnostic Test: Urinary Glycosaminoglycan

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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship of Lower Urinary System Symptoms Due to Benign Prostatic Hyperplasia and Urinary Glycosaminoglycan Level
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The value of glycosaminoglycan in predicting the success of medical treatment of benign prostatic hyperplasia [ Time Frame: one month ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who had benign prostatic hyperplasia with and without overactive bladder symptoms.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955484


Locations
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Turkey
Marmara University Recruiting
Istanbul, Turkey, 34000
Contact: Cagri Akin Sekerci, MD    0090 505 9139592    cagri_sekerci@hotmail.com   
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         
Sponsors and Collaborators
Marmara University

Publications:

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Responsible Party: Cagri Akin Sekerci, Urologist, Principal Investigator, MD, Marmara University
ClinicalTrials.gov Identifier: NCT03955484     History of Changes
Other Study ID Numbers: MAR.UAD.005
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cagri Akin Sekerci, Marmara University:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Medical Treatment
Urine Marker
Glycosaminoglycan

Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male