Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder

Bladder Cancer Clinical Trial

Official title:

Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077852
• Other study ID #: IPP-BC
• Status: Recruiting
• Start date: December 12, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Ankara Training and Research Hospital
• Contact: Ali Kaan Yildiz
• Phone: +90 554 773 16 96
• Email: alikaanyildiz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Bladder Cancer
• Hematuria
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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