Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms
Status:
Suspended
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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.