Prostatic HyperplasiaNCT03955484
Benign Prostatic Hyperplasia and Glycosaminoglycan
An observational study of Prostatic Hyperplasia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Urinary Glycosaminoglycan
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Adult, Older adult
Study population: Patients who had benign prostatic hyperplasia with and without overactive bladder symptoms.
Who may be able to join
None listed.
Who cannot join
- Patients who had undergone medical and surgical treatment for lower urinary tract symptoms
- Patients with accompanying urethral stricture
- Patients with neurological diseases (Parkinson's, Multiple Sclerosis etc ...)
- Patients with spinal cord trauma
- Patients with indication for surgical treatment at the time of initial admission (Macroscopic hematuria, bladder stone, urinary retention, upper urinary tract dilatation)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, 34000
Cagri Akin Sekerci, MD, 0090 505 9139592, cagri_sekerci@hotmail.com
Hasan Riza Aydin, Assoc. Prof.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Urinary Glycosaminoglycan
- Keywords
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Medical Treatment, Urine Marker, Glycosaminoglycan
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary GlycosaminoglycanDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Urinary Glycosaminoglycan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of glycosaminoglycan in predicting the success of medical treatment of benign prostatic hyperplasia
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Apr 2019
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagri Akin Sekerci, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955484
- Sponsor's protocol ID
- MAR.UAD.005
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 22 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23982767Bhide 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.
PubMed 23314226Suh 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.
PubMed 29298466Alkis 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.
PubMed 26661444Mashima 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.
PubMed 27331006Siracusano 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.
PubMed 19672549
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Lower Urinary System Symptoms Due to Benign Prostatic Hyperplasia and Urinary Glycosaminoglycan Level
- ClinicalTrials.gov ID
- NCT03955484
- Acronym / sponsor ID
- MAR.UAD.005
- Conditions
- Prostatic Hyperplasia
- Keywords
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Medical Treatment, Urine Marker, Glycosaminoglycan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who had benign prostatic hyperplasia | – | Diagnostic Test: Urinary GlycosaminoglycanMale 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients who had benign prostatic hyperplasia with and without overactive bladder symptoms.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients who had undergone medical and surgical treatment for lower urinary tract symptoms
- Patients with accompanying urethral stricture
- Patients with neurological diseases (Parkinson's, Multiple Sclerosis etc ...)
- Patients with spinal cord trauma
- Patients with indication for surgical treatment at the time of initial admission (Macroscopic hematuria, bladder stone, urinary retention, upper urinary tract dilatation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary GlycosaminoglycanUrine 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. | Diagnostic test | Patients who had benign prostatic hyperplasia |
Primary outcome
The value of glycosaminoglycan in predicting the success of medical treatment of benign prostatic hyperplasia
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Background: PubMed 23982767Wang 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.
- Background: PubMed 23314226Bhide 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.
- Background: PubMed 29298466Suh 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.
- Background: PubMed 26661444Alkis 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.
- Background: PubMed 27331006Mashima 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.
- Background: PubMed 19672549Siracusano 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of glycosaminoglycan in predicting the success of medical treatment of benign prostatic hyperplasia (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955484, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.