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Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection

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.
 
ClinicalTrials.gov Identifier: NCT02034890
Recruitment Status : Withdrawn (Difficulty in recruiting patients)
First Posted : January 14, 2014
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hanan Goldberg, Rabin Medical Center

Study Description
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Brief Summary:
Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: Hyaluronic Acid Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Is Intra - Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections?
Study Start Date : July 2015
Estimated Primary Completion Date : March 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: hyaluronic acid
intravesical instillation of 40 mg of hyaluronic acid at 6 specific time points: 1,2,3 and 4 weeks postoperatively 2 and 3 months postoperatively
 Drug: Hyaluronic Acid
intravesical instillation of 40 mg of hyaluronic acid in 6 specific time points: 1,2,3 and 4 weeks postoperatively (After radical cystectomy and orthotopic neobladder reconstruction) 2 and 3 months postoperatively
No Intervention: retrospective control patients
retrospective control patients


Outcome Measures
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Primary Outcome Measures :
  1. positive urinary culture [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. urinary tract infection [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing radical cystectomy and orthotopic neobladder reconstruction

Exclusion Criteria:

  • patients <18 years and unwilling to participate in this study
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02034890


Locations
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Israel
Urology department, Rabin Medical Center
Petach Tiqva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Hanan Goldberg, MD Rabin Medical Center
More Information
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Responsible Party: Hanan Goldberg, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02034890    
Other Study ID Numbers: RMC-7350
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2016
Keywords provided by Hanan Goldberg, Rabin Medical Center:
orthotopic neobladder
urinary tract infection
intravesical instillation
hyaluronic acid
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents