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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Hanan Goldberg, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02034890
First received: January 10, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  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
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 ]

Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Primary Completion Date: March 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034890

Contacts
Contact: Hanan Goldberg 972544315412 gohanan@gmail.com

Locations
Israel
Urology department, Rabin Medical Center Not yet recruiting
Petach Tiqva, Israel, 49100
Contact: Hanan Goldberg    972544315412      
Principal Investigator: Hanan Goldberg, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Hanan Goldberg, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Hanan Goldberg, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02034890     History of Changes
Other Study ID Numbers: RMC-7350
Study First Received: January 10, 2014
Last Updated: January 10, 2014
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:
Urinary Tract Infections
Infection
Urologic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014