Benign Prostatic HyperplasiaNCT07416981
Urinary CTGF in Benign Prostatic Obstruction
An observational study of Benign Prostatic Hyperplasia and Bladder Outlet Obstruction, run by Tarik Emre Sener.
Trial summary
Benign prostatic obstruction (BPO) is one of the most common causes of bladder outlet obstruction (BOO) and may lead to progressive structural and functional alterations in the bladder over time. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Bladder Outlet Obstruction, Lower Urinary Tract Symptom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study includes male patients older than 40 years with a diagnosis of benign prostatic obstruction (BPO) who have an indication for surgical treatment according to European Association of Urology (EAU) guidelines. Eligible patients may be catheterized or non-catheterized at the time of enrollment. Patients with conditions that may affect bladder function or connective tissue metabolism, including neurological diseases, diabetes mellitus, prior urogenital malignancy or surgery, urethral stricture, or previous pelvic radiotherapy or chemotherapy, are excluded.
Who may be able to join
- Male patients aged > 40 years
- Diagnosis of benign prostatic obstruction (BPO), with or without an indwelling catheter
- Patients with an indication for surgical treatment according to EAU guidelines
Who cannot join
- Age < 40 years
- Female sex
- Prostate-specific antigen (PSA) > 2.5 ng/mL
- History of endoscopic urological intervention
- Previous urogenital malignancy or urological surgery
- Diabetes mellitus
Show all 12Show fewer
- Urethral stricture
- History of pelvic radiotherapy and/or chemotherapy
- Patients performing clean intermittent catheterization
- Neurological diseases causing secondary urinary symptoms (e.g., spinal cord injury, stroke, multiple sclerosis, Parkinson's disease)
- History of spinal surgery
- History of colorectal cancer or previous colorectal surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Relationship of Urinary CTGF Levels With Bladder Fibrosis and Surgical Treatment Response in Patients With Benign Prostatic Obstruction
Benign prostatic obstruction (BPO) is one of the most common causes of bladder outlet obstruction (BOO) and may lead to progressive structural and functional alterations in the bladder over time. Prolonged obstruction triggers a bladder remodeling process characterized by detrusor hypertrophy, ischemia-reperfusion injury, smooth muscle loss, and progressive fibrosis. These pathological changes may result in impaired detrusor contractility, increased post-void residual volume, and suboptimal functional recovery following surgical treatment.
Connective tissue growth factor (CTGF) is a matricellular protein that plays a key role in fibrogenesis and is markedly upregulated under hypoxic, ischemia-reperfusion, and inflammatory conditions. Experimental and cellular studies have demonstrated that CTGF promotes fibroblast proliferation, extracellular matrix production, and collagen deposition, thereby contributing to bladder fibrosis. Increased CTGF expression has also been associated with fibrotic differentiation of bladder smooth muscle cells.
The aim of this observational study is to evaluate the relationship between urinary CTGF levels, bladder fibrosis, and functional response to surgical treatment in patients with benign prostatic obstruction. Preoperative urinary CTGF levels will be assessed and correlated with postoperative functional outcomes and clinical improvement. This study aims to determine whether urinary CTGF may serve as a non-invasive biomarker of bladder fibrosis and a potential predictor of surgical treatment response in patients with BPO.
- Being tested
- None-placebo
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder Neck Obstruction, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-placeboOther
No intervention is assigned as part of this observational study. All diagnostic and surgical procedures are performed as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Benign Prostatic Obstruction Patients | Not described Receives: Other: None-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary CTGF Level
Preoperative urinary connective tissue growth factor (CTGF) levels measured to evaluate their association with bladder fibrosis and postoperative functional outcomes.
Measured: Baseline, measured within 1 week prior to surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarik Emre Sener
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416981
- Sponsor's protocol ID
- MAR.UAD.0029
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Urinary CTGF Levels With Bladder Fibrosis and Surgical Treatment Response in Patients With Benign Prostatic Obstruction
- ClinicalTrials.gov ID
- NCT07416981
- Acronym / sponsor ID
- MAR.UAD.0029
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tarik Emre SenerUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
Benign prostatic obstruction (BPO) is one of the most common causes of bladder outlet obstruction (BOO) and may lead to progressive structural and functional alterations in the bladder over time. Prolonged obstruction triggers a bladder remodeling process characterized by detrusor hypertrophy, ischemia-reperfusion injury, smooth muscle loss, and progressive fibrosis. These pathological changes may result in impaired detrusor contractility, increased post-void residual volume, and suboptimal functional recovery following surgical treatment.
Connective tissue growth factor (CTGF) is a matricellular protein that plays a key role in fibrogenesis and is markedly upregulated under hypoxic, ischemia-reperfusion, and inflammatory conditions. Experimental and cellular studies have demonstrated that CTGF promotes fibroblast proliferation, extracellular matrix production, and collagen deposition, thereby contributing to bladder fibrosis. Increased CTGF expression has also been associated with fibrotic differentiation of bladder smooth muscle cells.
The aim of this observational study is to evaluate the relationship between urinary CTGF levels, bladder fibrosis, and functional response to surgical treatment in patients with benign prostatic obstruction. Preoperative urinary CTGF levels will be assessed and correlated with postoperative functional outcomes and clinical improvement. This study aims to determine whether urinary CTGF may serve as a non-invasive biomarker of bladder fibrosis and a potential predictor of surgical treatment response in patients with BPO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benign Prostatic Obstruction Patients | – | Other: None-placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes male patients older than 40 years with a diagnosis of benign prostatic obstruction (BPO) who have an indication for surgical treatment according to European Association of Urology (EAU) guidelines. Eligible patients may be catheterized or non-catheterized at the time of enrollment. Patients with conditions that may affect bladder function or connective tissue metabolism, including neurological diseases, diabetes mellitus, prior urogenital malignancy or surgery, urethral stricture, or previous pelvic radiotherapy or chemotherapy, are excluded.
Key inclusion criteria (3 listed)
- Male patients aged > 40 years
- Diagnosis of benign prostatic obstruction (BPO), with or without an indwelling catheter
- Patients with an indication for surgical treatment according to EAU guidelines
Key exclusion criteria (12 listed)
- Age < 40 years
- Female sex
- Prostate-specific antigen (PSA) > 2.5 ng/mL
- History of endoscopic urological intervention
- Previous urogenital malignancy or urological surgery
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 |
|---|---|---|
| None-placeboNo intervention is assigned as part of this observational study. All diagnostic and surgical procedures are performed as part of routine clinical care. | Other | Benign Prostatic Obstruction Patients |
Primary outcome
Urinary CTGF Level
Time frame: Baseline, measured within 1 week prior to surgical treatment
Preoperative urinary connective tissue growth factor (CTGF) levels measured to evaluate their association with bladder fibrosis and postoperative functional outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia and Bladder Outlet Obstruction, run by Tarik Emre Sener.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarik Emre Sener, Associated Professor (90 (534) 452 57 00, emre.sener@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary CTGF Level (time frame: Baseline, measured within 1 week prior to surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2026.