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Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms

NCT03549650 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-03-04

No results posted yet for this study

Summary

Common local side effects are generally seen during induction and during the first 6 months of BCG maintenance. BCG-related cystitis is frequent and unavoidable. Furthermore, repeated BCG instillation increases the incidence and severity of irritative bladder symptoms. Several methods attempted to reduce the intensity and frequency of BCG- related lower urinary tract symptoms (LUTS), such as, administration of anti-tuberculosis drug isoniazid or oral antibiotic ofloxacin or by reducing the BCG dose, but without any encouraging results. Local side effects requiring cessation of treatment are seen more frequently in the first year of therapy, preventing patients from receiving their BCG maintenance regimen.

Pentosan Polysulphate (PPS), is an oral medication with unique analgesic properties used to relieve bladder pain and discomfort related to other conditions, has been investigated in a small study with encouraging result in this patient population. This suggest that PPS is well tolerated and effective at decreasing BCG-related LUTS.

The purpose of this study is first to investigate the efficacy of co-administration of Pentosan Polysulphate to prevent these adverse events and the impact of this intervention on quality of life. The second goal is to determine which patients are more vulnerable to develop BCG- related lower urinary tract symptoms (LUTS), based on clinical assessment, demographics data, voiding parameters, and urinary inflammatory markers, and then to assess the effectiveness of BCG therapy following co-administration of ELMIRON.

Conditions

  • Lower Urinary Tract Symptoms
  • Bladder Carcinoma
  • BCG

Interventions

DRUG

Pentosan Polysulfate Na 100Mg Cap

Participants will be randomly assigned to receive Pentosan Polysulfate Na 100Mg Cap TID for 6 weeks. For blinded distribution, each bottle of medications will be labeled with a random number for identification. The study participants will be monitored every 2 weeks with phone calls from the study team to evaluate their condition and decide if the medication is tolerated and whether it should be continued or stopped.

DRUG

Placebo oral capsule

Participants will be randomly assigned to receive Placebo oral capsule TID for 6 weeks. For blinded distribution, each bottle of medications will be labeled with a random number for identification. The study participants will be monitored every 2 weeks with phone calls from the study team to evaluate their condition and decide if the medication is tolerated and whether it should be continued or stopped.

Sponsors & Collaborators

  • Cancer Research Network

    collaborator OTHER

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Principal Investigators

  • Lysanne Campeau, MD, PhD · SirMortimer JGH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2022-02-15
Completion
2022-02-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549650 on ClinicalTrials.gov