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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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Hanan Goldberg, Rabin Medical Center Identifier:
First received: January 10, 2014
Last updated: April 4, 2016
Last verified: April 2016
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Rabin Medical Center:

Primary Outcome Measures:
  • positive urinary culture [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary tract infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT02034890

Urology department, Rabin Medical Center
Petach Tiqva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: Hanan Goldberg, MD Rabin Medical Center
  More Information

Responsible Party: Hanan Goldberg, MD, Rabin Medical Center Identifier: NCT02034890     History of Changes
Other Study ID Numbers: RMC-7350 
Study First Received: January 10, 2014
Last Updated: April 4, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
orthotopic neobladder
urinary tract infection
intravesical instillation
hyaluronic acid

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on December 09, 2016