Benign Prostatic Hyperplasia and Glycosaminoglycan

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

More Information

Publications:

Wang LW, Han XM, Chen CH, Ma Y, Hai B. Urinary brain-derived neurotrophic factor: a potential biomarker for objective diagnosis of overactive bladder. Int Urol Nephrol. 2014 Feb;46(2):341-7. doi: 10.1007/s11255-013-0540-x. Epub 2013 Aug 28.

Bhide AA, Cartwright R, Khullar V, Digesu GA. Biomarkers in overactive bladder. Int Urogynecol J. 2013 Jul;24(7):1065-72. doi: 10.1007/s00192-012-2027-1. Epub 2013 Jan 12. Erratum In: Int Urogynecol J. 2013 Oct;24(10):1775-6.

Suh YS, Ko KJ, Kim TH, Lee HS, Sung HH, Cho WJ, Lee KS. Urinary Nerve Growth Factor as a Potential Biomarker of Treatment Outcomes in Overactive Bladder Patients. Int Neurourol J. 2017 Dec;21(4):270-281. doi: 10.5213/inj.1732794.397. Epub 2017 Dec 31.

Alkis O, Zumrutbas AE, Toktas C, Aybek H, Aybek Z. The use of biomarkers in the diagnosis and treatment of overactive bladder: Can we predict the patients who will be resistant to treatment? Neurourol Urodyn. 2017 Feb;36(2):390-393. doi: 10.1002/nau.22939. Epub 2015 Dec 10.

Mashima R, Sakai E, Tanaka M, Kosuga M, Okuyama T. The levels of urinary glycosaminoglycans of patients with attenuated and severe type of mucopolysaccharidosis II determined by liquid chromatography-tandem mass spectrometry. Mol Genet Metab Rep. 2016 Apr 22;7:87-91. doi: 10.1016/j.ymgmr.2016.03.009. eCollection 2016 Jun.

Siracusano S, Cucchi A, Ciciliato S, Lampropoulou N, Vittur F. Urinary levels of glycosaminoglycans in patients with idiopathic detrusor overactivity. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Dec;20(12):1477-80. doi: 10.1007/s00192-009-0973-z. Epub 2009 Aug 12.

• Responsible Party: Cagri Akin Sekerci, Urologist, Principal Investigator, MD, Marmara University
• ClinicalTrials.gov Identifier: NCT03955484
• Other Study ID Numbers: MAR.UAD.005
• First Posted: May 20, 2019
• Last Update Posted: May 22, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases