Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder

NCT05077852 | Unknown

• 1 other identifier: IPP-BC
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Benign Prostatic Hyperplasia; Hematuria

Keywords

Bladder cancer; Benign prostatic hyperplasia; Hematuria; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cystoscopy Bladder Cancer

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

Diagnostic Test: Urethrocystoscopy

Cystoscopy IPP

Patients diagnosed with intravesical prostate protrusion (IPP) at the base, trigone or neck of the bladder by cystoscopy.

Diagnostic Test: Urethrocystoscopy

Interventions

Urethrocystoscopy DIAGNOSTIC_TEST

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 Bladder Cancer; Cystoscopy IPP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 32322764 BACKGROUND

• 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.

  PMID: 30374274 BACKGROUND

• 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.

  PMID: 27317986 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Hyperplasia; Hematuria

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Kaan Yildiz

  Ankara Training and Resarch Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Kaan Yildiz

CONTACT

+90 554 773 16 96; alikaanyildiz@gmail.com

Esra Gulen Yildiz

CONTACT

+90 506 877 47 09; esragln90@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 14, 2021
• Study Start: December 12, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)