Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder

• Conditions: Bladder Cancer; Benign Prostatic Hyperplasia; Hematuria
• Interventions: Diagnostic Test: Urethrocystoscopy

• Registration Number: NCT05077852
• Lead Sponsor: Ankara Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-14
• Study Start: 2021-12-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 194

Inclusion Criteria

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

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cystoscopy Bladder Cancer	Urethrocystoscopy	Patients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by cystoscopy.
Cystoscopy IPP	Urethrocystoscopy	Patients diagnosed with intravesical prostate protrusion (IPP) at the base, trigone or neck of the bladder by cystoscopy.

Primary Outcome Measures

Name	Time	Method
Rate of a positive screening test truly have the bladder cancer	3 months	Rate of a positive screening test truly have the bladder cancer in patients who diagnosed with bladder cancer at the base, trigone or neck by USG

Trial Locations

Locations (1)

Ankara Training and Research Hospital; 🇹🇷 Ankara, Altindag, Turkey