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

This study has been withdrawn prior to enrollment.
(Difficulty in recruiting patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02034890
First Posted: January 14, 2014
Last Update Posted: April 6, 2016
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.
Information provided by (Responsible Party):
Hanan Goldberg, Rabin Medical Center
  Purpose
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 Intervention Phase
Urinary Tract Infection Drug: Hyaluronic Acid Phase 4

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Hanan Goldberg, Rabin Medical Center:

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

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

Enrollment: 0
Study Start Date: July 2015
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Israel
Urology department, Rabin Medical Center
Petach Tiqva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Hanan Goldberg, MD Rabin Medical Center
  More Information

Responsible Party: Hanan Goldberg, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02034890     History of Changes
Other Study ID Numbers: RMC-7350
First Submitted: January 10, 2014
First Posted: January 14, 2014
Last Update Posted: April 6, 2016
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:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents