Urinary CTGF in Benign Prostatic Obstruction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia; Bladder Outlet Obstruction; Lower Urinary Tract Symptom
• Intervention / Treatment: Other: None-placebo

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Tarik Emre Sener, Associated Professor; Phone Number: 90 (534) 452 57 00; Email: emre.sener@marmara.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Benign Prostatic Obstruction Patients	Other: None-placebo; No intervention is assigned as part of this observational study. All diagnostic and surgical procedures are performed as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary CTGF Level	Preoperative urinary connective tissue growth factor (CTGF) levels measured to evaluate their association with bladder fibrosis and postoperative functional outcomes.	Baseline, measured within 1 week prior to surgical treatment

Collaborators and Investigators

• Sponsor: Tarik Emre Sener

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urological Manifestations; Urinary Bladder Diseases; Urethral Diseases; Urethral Obstruction; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: MAR.UAD.0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No