Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder

Last updated: February 28, 2022
Sponsor: Ankara Training and Research Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Bladder Disorders

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT05077852
IPP-BC
  • Ages 18-90
  • Male

Study Summary

In this study, investigators aim to determine the true positivity of bladder cancer identified in the bladder base, trigone or neck on ultrasonography (USG) in patients presenting with hematuria or lower urinary tract symptoms, by confirming with the gold standard cystoscopy and biopsy results. It also aims to explore criteria that would allow to differentiate between intravesical prostate protrusion (IPP) due to benign prostatic hyperplasia (BPH) and bladder cancer indicated at the bladder floor, trigone and neck by evaluating false positive results.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hematuria
  • Patients diagnosed with primary bladder cancer at the base, trigone or neck of thebladder by USG.

Exclusion

Exclusion Criteria:

  • Previous history of urinary tract tumor
  • Chronic kidney disease
  • Use of antimuscarinic drugs
  • Active urinary tract infection
  • Bladder stone
  • Previous history of lower urinary tract surgery or urethral stricture

Study Design

Total Participants: 194
Study Start date:
December 12, 2021
Estimated Completion Date:
December 30, 2022

Study Description

The most common symptom in bladder cancer is hematuria, although the rate of bladder cancer is 18.9% in patients presenting with gross hematuria and 4.8% in patients presenting with microscopic hematuria. For this reason, unnecessary and invasive procedures are applied to most of the patients investigated. USG is considered the first-line imaging technique in the evaluation of upper and lower urinary tract disease. It is a non-invasive technique that does not involve ionizing radiation, and can be used in the evaluation of kidney, prostate and bladder anatomy. In addition, USG is used to evaluate malignant tumors of the urinary system or benign causes such as BPH, urinary tract stones that may cause hematuria. Cystoscopy is the gold standard test for diagnosing bladder cancer, but cystoscopy causes discomfort and can carry risks such as infection and bleeding. Suspicious findings as a result of USG imaging may lead to more invasive tests such as cystoscopy. An example of this is performing a biopsy under general anesthesia to confirm a positive or negative finding. The annual costs of these examinations, which emerge as further examinations as a result of incorrect evaluations, are important. In England, patients with hematuria and normal investigation cost the National Health Service £33.5 million in one year.

IPP, or median lobe, is a phenomenon in which the prostate adenoma expands into the bladder along the plane of lowest resistance. IPP originating from the base of the prostate may enlarge and protrude into the bladder and form a regional lesion on the neck, trigone and posterior wall of the bladder. IPP cannot be detected adequately by conventional digital rectal examination (DRE), nor can it be diagnosed with sufficient accuracy by examinations such as noninvasive USG. In the literature, some studies evaluated the diagnosis of IPP by USG, and the full spectrum of IPP was not defined due to the scarcity of clinical series. IPP is seen as protruding structures within the bladder in the coronal plane of USG and can be easily misdiagnosed as a bladder-derived lesion. Thus, IPP, which is a manifestation of BPH, located at the base of the prostate and extending into the bladder, can easily be misdiagnosed as bladder cancer.

Connect with a study center

  • Ankara Training and Research Hospital

    Ankara, Altindag 06230
    Turkey

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.