Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia; Bladder Cancer; Hematuria
• Intervention / Treatment: Diagnostic test: Urethrocystoscopy

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 Type: Observational
• Enrollment (Anticipated): 194

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey, 06230
      • Recruiting
      • Ankara Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cystoscopy Bladder Cancer; Patients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by cystoscopy.	Diagnostic test: Urethrocystoscopy; Patients diagnosed with a primary bladder cancer at the base, trigone or neck of the bladder with USG in the urology clinic will be evaluated with urethrocystoscopy. With urethrocystoscopy, patients definitive diagnosed with bladder cancer and IPP.
Cystoscopy IPP; Patients diagnosed with intravesical prostate protrusion (IPP) at the base, trigone or neck of the bladder by cystoscopy.	Diagnostic test: Urethrocystoscopy; Patients diagnosed with a primary bladder cancer at the base, trigone or neck of the bladder with USG in the urology clinic will be evaluated with urethrocystoscopy. With urethrocystoscopy, patients definitive diagnosed with bladder cancer and IPP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of a positive screening test truly have the bladder cancer	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	3 months

Collaborators and Investigators

• Sponsor: Ankara Training and Research Hospital

Publications and helpful links

General Publications

• Khadhouri S, Gallagher KM, MacKenzie K, Shah TT, Gao C, Moore S, Zimmermann E, Edison E, Jefferies M, Nambiar A, MacLennan G, McGrath JS, Kasivisvanathan V; IDENTIFY Protocol Collaborators Group. IDENTIFY: The investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer: A multicentre cohort study. Int J Surg Protoc. 2020 Feb 28;21:8-12. doi: 10.1016/j.isjp.2020.02.002. eCollection 2020.
• Gandhi J, Weissbart SJ, Kim AN, Joshi G, Kaplan SA, Khan SA. Clinical Considerations for Intravesical Prostatic Protrusion in the Evaluation and Management of Bladder Outlet Obstruction Secondary to Benign Prostatic Hyperplasia. Curr Urol. 2018 Oct;12(1):6-12. doi: 10.1159/000447224. Epub 2018 Jun 30. Review.
• Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Bladder cancer; Ultrasonography; Hematuria; Benign prostatic hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Hemorrhage; Prostatic Diseases; Urination Disorders; Prostatic Hyperplasia; Hyperplasia; Urinary Bladder Neoplasms; Hematuria
• Other Study ID Numbers: IPP-BC

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