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Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03038321
Recruitment Status : Unknown
Verified March 2017 by Abdelwahab Hashem, Mansoura University.
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Abdelwahab Hashem, Mansoura University

Brief Summary:
Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)

Condition or disease Intervention/treatment Phase
Non-Muscle-invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guerin (BCG) Cystitis Intra-vesical Instillation Drug: sofenacin Drug: Tavanic Drug: Xefo Phase 4

Detailed Description:

For urothelial carcinoma (UC), which accounts for over 90% of bladder cancers, more than 70% of bladder cancer patients present with non‐muscle‐invasive disease. Approximately 40-80% of these tumors will recur within the first year, of which 10-25% will progress to muscle‐invasive disease.

Intravesical treatments with cytotoxic chemotherapy and immunotherapy have become the mainstay following transurethral resection (TUR). Increasing knowledge of BCG use allows for effective management of these once debilitating side effects. The majority of patients will still experience cystitis‐like symptoms to some degree, including urinary frequency (71%), cystitis (67%), fever (25%), and hematuria (23%).

Oxybutynin increases in fever, flu-like symptoms, dry mouth and constipation. However, in this study oxybutynin started the night before treatment causing an element of incomplete bladder emptying and allowing an increased BCG dwell time. We think that these effect can be reversed by use anticholinergic 6 hours post BCG instillation Anti-inflammatory drugs significantly reduced BCG-induced granulocyte activation and did not impair BCG-induced lymphocyte cytotoxicity against bladder tumor cells in mice. The committee of International Bladder Cancer Group (IBCG) recommend use of anti-inflammatory agents (NSAIDs) for treatment of non-bacterial or chemical cystitis and other systemic BCG side effect.

Fluoroquinolone with tuberculostatic properties, has been shown to significantly prolong survival in mice with BCG systemic infection and did not affect the antitumor efficacy of BCG. ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events of BCG.

Because of sparse published studies on BCG side effect management, the 2016 European Association of Urology (EAU) guidelines management options for side effects associated with intravesical BCG modify the IBCG committee clinical practice without any degree of recommendation. So, in this study the investigators will try to fill the gap in the literature.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Solifenacin vs Levofloxacin vs Lornoxicam for Management of Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Side Effects A Single Blinded Randomised Controlled Study
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: solifenacin
(Sofenacin ''solifenacin 10 m'') [Marcyrl Pharmaceutical Industries - Egypt]
Drug: sofenacin
solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation
Other Name: Solfenacin 10 mg

Active Comparator: levofloxacin
(Tavanic ''levofloxacin 500 mg'') [Sanofi-Aventis - Egypt]
Drug: Tavanic
levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
Other Name: levofloxacin 500

Active Comparator: lornoxicam
(Xefo ''lornoxicam 8 mg'') [Multi-Apex - Egypt, under license of: NYCOMED, Austria]
Drug: Xefo
lornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
Other Name: lornoxicam

Primary Outcome Measures :
  1. Comparing the drugs efficacy on decreasing systemic and local side effects of BCG [ Time Frame: 6 weeks ]
    __ Outcome Measure by Four-class classification grid of BCG adverse events

Secondary Outcome Measures :
  1. Comparing the drugs effect on decreasing voiding and storage urinary symptoms of BCG [ Time Frame: 6 weeks ]
    __ Outcome Measure by overactive bladder symptoms scores and American Urological Association Symptom Index

  2. Prostatic specific antigen (PSA) change [ Time Frame: 1 month and 3 months ]
    __ Outcome Measure by PSA measure 1 and 3 months post instillation

  3. recurrence free survival [ Time Frame: 1 year ]
    __ Outcome Measure by Number of patients surviving for one year without tumor recurrence will be counted and compared

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

• Patients classified as intermediate or high risk of the bladder tumour

Exclusion Criteria:

  • Patient over 80 years (natural decline in immune system function)
  • Refuse to complete study requirements
  • Contraindication to BCG therapy
  • High post-void residual (PVR) above 85 ml
  • American Urological Association (AUA) Symptoms score above 20
  • Sensitivity to previously mentioned 3 drugs
  • High serum creatinine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03038321

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Urology and Nephrology Center
Mansoura, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
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Study Chair: Hassan Abol-Enein, MD, Phd Urology and Nephrology Center
Study Director: Ahmed Mosbah, MD Urology and Nephrology Center
Principal Investigator: Ahmed Elhussein, MBBCH Urology and Nephrology Center
Principal Investigator: Ahmed Elkarta, MBBCH Urology and Nephrology Center
Principal Investigator: Mohamed Soltan Urology and Nephrology Center

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Responsible Party: Abdelwahab Hashem, Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator, Mansoura University Identifier: NCT03038321    
Other Study ID Numbers: R/17.01.02
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abdelwahab Hashem, Mansoura University:
BCG Cystitis
Bladder Cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Solifenacin Succinate
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents