Urinary CTGF in Benign Prostatic Obstruction

NCT07416981 | Not Yet Recruiting

• 1 other identifier: MAR.UAD.0029
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Benign Prostatic Hyperplasia; Bladder Outlet Obstruction; Lower Urinary Tract Symptom

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Benign Prostatic Obstruction Patients

Other: None-placebo

Interventions

None-placebo OTHER

No intervention is assigned as part of this observational study. All diagnostic and surgical procedures are performed as part of routine clinical care.

Benign Prostatic Obstruction Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarik Emre Sener: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tarik Emre Sener, Associated Professor

CONTACT

90 (534) 452 57 00; emre.sener@marmara.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share