Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection
Overview[ - collapse ][ - ]
| 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 | Urinary Tract Infection |
| Intervention | Drug: Hyaluronic Acid |
| Phase | Phase 4 |
| Sponsor | Rabin Medical Center |
| Responsible Party | Rabin Medical Center |
| ClinicalTrials.gov Identifier | NCT02034890 |
| First Received | January 10, 2014 |
| Last Updated | January 10, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 10, 2014 |
|---|---|
| Last Updated Date | January 10, 2014 |
| Start Date | March 2014 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | positive urinary culture [Time Frame: 6 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | urinary tract infection [Time Frame: 6 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection |
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| Official Title | Is Intra - Neobladder Installations of Hyaluronic Acid, Effective in Reducing Neobladder Orthotropic Reconstruction Post-operative Urinary Tract Infections? |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention |
| Condition | Urinary Tract Infection |
| Intervention | 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | March 2016 |
| Eligibility Criteria | Inclusion Criteria: - patients undergoing radical cystectomy and orthotopic neobladder reconstruction Exclusion Criteria: - patients <18 years and unwilling to participate in this study |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Hanan Goldberg 972544315412 gohanan@gmail.com |
| Location Countries | Israel |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02034890 |
|---|---|
| Other Study ID Numbers | RMC-7350 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Rabin Medical Center |
| Study Sponsor | Rabin Medical Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Hanan Goldberg, MD Rabin Medical Center |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| Urology department, Rabin Medical Center | Petach Tiqva, Israel, 49100 Contact: Hanan Goldberg | 972544315412Principal Investigator: Hanan Goldberg, MD Not yet recruiting |
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