Back to resultsIntravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection
Primary Purpose
Urinary Tract Infection
Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infection focused on measuring orthotopic neobladder, urinary tract infection, intravesical instillation, hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- patients undergoing radical cystectomy and orthotopic neobladder reconstruction
Exclusion Criteria:
- patients <18 years and unwilling to participate in this study
Sites / Locations
- Urology department, Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hyaluronic acid
retrospective control patients
Arm Description
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
retrospective control patients
Outcomes
Primary Outcome Measures
positive urinary culture
Secondary Outcome Measures
urinary tract infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02034890
Brief Title
Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection
Official Title
Is Intra - Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in recruiting patients
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
orthotopic neobladder, urinary tract infection, intravesical instillation, hyaluronic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hyaluronic acid
Arm Type
Experimental
Arm Description
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
Arm Title
retrospective control patients
Arm Type
No Intervention
Arm Description
retrospective control patients
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Intervention Description
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
Primary Outcome Measure Information:
Title
positive urinary culture
Time Frame
6 months
Secondary Outcome Measure Information:
Title
urinary tract infection
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing radical cystectomy and orthotopic neobladder reconstruction
Exclusion Criteria:
patients <18 years and unwilling to participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanan Goldberg, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology department, Rabin Medical Center
City
Petach Tiqva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection
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