Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer

NCT05675176 | Completed FDA Drug

• 1 other identifier: 15306/26-7-22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study compares the complications caused after the BCG intravesical instillation in patients treated for non invasive bladder cancer.The patients are divided into two groups one receiving IVI (intravesical Instillations) with the use of latex catheter while in the other silicone catheter is used.The two groups are compared in terms of fever, hematuria, LUTS and other complications following IVI.

Conditions

Non-muscle-invasive Bladder Cancer

Keywords

bladder cancer; intravesical instillation; complications; BCG; hematuria; fever; LUTS; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Complications

  Complications in both groups- hematuria, fever, LUTS , systemic symptoms

  1.5 year

Study Arms (2)

Group 1

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of self lubricated silicon tiemann 10 fr urinary catheter.

Drug: BCG

Group 2

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of straight tipped latex foley 14 fr urinary catheter

Drug: BCG

Interventions

BCG DRUG

Intravesical Instillation

Also known as: Intravesical Instillation

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with BCG.

You may qualify if:

• BCG intravesical instillation for non muscle invasive bladder cancer

You may not qualify if:

• Positive culture
• Preexisting LUTS
• Muscle invasive bladder cancer

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Themistoklis Bellos

Marathon, Attica, 19007, Greece

Location

Related Publications (4)

• Nacey JN, Tulloch AG, Ferguson AF. Catheter-induced urethritis: a comparison between latex and silicone catheters in a prospective clinical trial. Br J Urol. 1985 Jun;57(3):325-8. doi: 10.1111/j.1464-410x.1985.tb06354.x.

  PMID: 3891005 BACKGROUND

• Stenzelius K, Persson S, Olsson UB, Stjarneblad M. Noble metal alloy-coated latex versus silicone Foley catheter in short-term catheterization: a randomized controlled study. Scand J Urol Nephrol. 2011 Sep;45(4):258-64. doi: 10.3109/00365599.2011.560007. Epub 2011 Mar 31.

  PMID: 21452931 BACKGROUND

• Liu Y, Lu J, Huang Y, Ma L. Clinical Spectrum of Complications Induced by Intravesical Immunotherapy of Bacillus Calmette-Guerin for Bladder Cancer. J Oncol. 2019 Mar 10;2019:6230409. doi: 10.1155/2019/6230409. eCollection 2019.

  PMID: 30984262 BACKGROUND

• Talja M, Korpela A, Jarvi K. Comparison of urethral reaction to full silicone, hydrogen-coated and siliconised latex catheters. Br J Urol. 1990 Dec;66(6):652-7. doi: 10.1111/j.1464-410x.1990.tb07203.x.

  PMID: 2265339 RESULT

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Hematuria; Fever; Tuberculosis

Interventions

Administration, Intravesical

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: April 12, 2020
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

GR (1)