Drug intervention of Pentosan Polysulfate Na 100Mg Cap (ELMIRON) thrice daily PO for 6 weeks, after meeting the eligibility criteria during the the two-week Screening period.

Participants will receive Placebo oral capsule, similar to (ELMIRON 100mg) thrice daily PO for 6 weeks, , after meeting the eligibility criteria during the the two-week Screening period.

Lower Urinary Tract Symptoms

Bladder Carcinoma

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.

Pentosan Polysulfate Na 100Mg Cap

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.

Placebo oral capsule

Jewish General Hospital

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

Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms With Prophylactic Pentosan Polysulphate in Patients With Non-Muscle-Invasive Bladder Cancer: A Randomized Controlled Trial

Primary outcome assessment (change from baseline to end of treatment):
-Mean change in number of urgency episodes per 24 hours based on a 3-day bladder diary

Primary outcome assessment (change from baseline to end of treatment):
-Mean change in ICIQ-LUTSqol questionnaire score

Primary outcome assessment (change from baseline to end of treatment):
-Mean change in OAB-V8 questionnaire score

Safety: (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)
-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 at the End of treatment Visit (week 6)

All patients will be also evaluated at 12 and 24 weeks by cystoscopy to evaluate the impact of this intervention on the efficacy of BCG therapy as well as to check for cancer recurrence and progression as routine standard of care

All patients will be also evaluated at 12 and 24 weeks by urine cytology to evaluate the impact of this intervention on the efficacy of BCG therapy as well as to check for cancer recurrence and progression as routine standard of care

This will involve an in-depth pre-treatment analysis of clinical parameters of patients planned for BCG instillation and correlation with the development of BCG local side effects

Objective outcomes assessment using quantitative measures of TRAIL, IFN, IL-2, and IL-10 levels in the urine before and following BCG induction treatment will be quantitated using a sandwich ELISA and correlated with the severity of LUTS

Assess the impact of this intervention on Health-related quality of life (HRQoL) in bladder cancer patients using quality of life questionnaire ICIQ-LUTSqol

Assess the impact of this intervention on Health-related quality of life (HRQoL) in bladder cancer patients using quality of life questionnaire VAS

Lysanne Campeau, MDCM, PhD, FRCSC

Assistant Professor

Sir Mortimer B. Davis - Jewish General Hospital

Cancer Research Network

Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone

Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).

Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone
BCG (Immucist®)

BCG Alone (Immucist®)

Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).
Hyaluronic Acid
BCG (Immucist®)

Hyaluronic Acid

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)

Visual Analogue Scale for Pain

Overall Study

Prof. Enrico Finazzi Agro

Poisoning by BCG Vaccine

BCG (Immucist®)

Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects

Pilot Study of Influence of Hyaluronic Acid (HA) on Bacillus Calmette-Guérin (BCG) Local Side Effects

Enrico Finazzi Agro

Associate Professor

University of Rome Tor Vergata

Placebo instillation: 20 ml of normal saline instilled intravesically

The experimental instillation will include 8 ml of 2% lidocaine, 3 ml of sodium bicarbonate, and 9 ml of normal saline.

Interstitial Cystitis

A small catheter will be inserted into the bladder and water will slowly be instilled through the catheter and into your bladder. A series of measurements will then be taken to assess your bladder's capacity to hold liquid, the average and maximum urine flow rates, as well as bladder filling and leak point pressure readings.

Urodynamic study

20 cc of alkalinized lidocaine will be injected after the first UDS

Lidocaine

20 cc of normal saline will be injected into the bladder after the first UDS

pentosan/saratani

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

Influence of Hyaluronic Acid on Bacillus Calmette-Guérin Local Side Effects

Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis

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