ClinicalTrials.gg
Not yet recruitingNCT07416981Updated Feb 18, 2026

Urinary CTGF in Benign Prostatic Obstruction

An observational study in Benign Prostatic Hyperplasia, Bladder Outlet Obstruction and Lower Urinary Tract Symptom, sponsored by Tarik Emre Sener. Not yet recruiting. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Tarik Emre Sener · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
40 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Benign Prostatic Hyperplasia
  • Bladder Outlet Obstruction
  • Lower Urinary Tract Symptom
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In context

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

This study's planned enrollment of 50 is below the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Tarik Emre Sener is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age \< 40 years
  • Female sex
  • Prostate-specific antigen (PSA) > 2.5 ng/mL
  • History of endoscopic urological intervention
  • Previous urogenital 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Benign Prostatic Obstruction Patients

    Other: None-placebo

Interventions

  • OtherNone-placebo

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

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What researchers measure

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.

    Time frame: Baseline, measured within 1 week prior to surgical treatment

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Oct 2026, 6 months later.

Of 59 non-industry observational studies under Prostatic Hyperplasia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's planned 6 months is below that.

Counting every sponsor, half of 74 studies reached it within 25 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2026
First posted
Feb 18, 2026
StartEst.
Apr 1, 2026
Primary completionEst.
Oct 1, 2026
CompletionEst.
Dec 1, 2026
Last update
Feb 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07416981
Lead sponsor
Tarik Emre Sener
Responsible party
Tarik Emre Sener (Associated Professor, Marmara University) — Sponsor-investigator
First posted
Feb 18, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Feb 18, 2026

Study contacts

Tarik Emre Sener, Associated Professor
Contact
emre.sener@marmara.edu.tr
90 (534) 452 57 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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