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

Overview

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.

Full Title of Study: “Is Intra – Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2017

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • No Intervention: retrospective control patients
    • retrospective control patients

Clinical Trial Outcome Measures

Primary Measures

  • positive urinary culture
    • Time Frame: 6 months

Secondary Measures

  • urinary tract infection
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • patients undergoing radical cystectomy and orthotopic neobladder reconstruction Exclusion Criteria:

  • patients <18 years and unwilling to participate in this study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rabin Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hanan Goldberg, MD – Rabin Medical Center
  • Overall Official(s)
    • Hanan Goldberg, MD, Principal Investigator, Rabin Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.