Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation

Phase 2

Completed

• Conditions: Urinary Catheter Blockage and Encrustation
• Interventions: Drug: NVC-422, 0.2%; Drug: Sterile normal saline, 0.9%

• Registration Number: NCT01243125
• Lead Sponsor: NovaBay Pharmaceuticals, Inc.

Brief Summary

NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others.

The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs, and better patient quality of life.

The study population will include male and female spinal cord injury (SCI) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage.

Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. Each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-18
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2014-08
• Disposition First Submitted: 2014-08-04
• Disposition First Submitted QC: 2014-08-04
• Last Update Submitted: 2014-08-04
• Disposition First Posted: 2014-08-07
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
• Screening within 30 days of first treatment

Exclusion Criteria

• Systemic antibiotics within 7 days of first treatment
• Investigational drug or device within 30 days of enrollment
• Current infection that requires treatment with systemic antibiotics
• Recent history of significant autonomic dysreflexia (requiring intervention or treatment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NVC-422	NVC-422, 0.2%	-
Saline	Sterile normal saline, 0.9%	-

Primary Outcome Measures

Name	Time	Method
Catheter patency following treatment	26 days	Cross sectional area (percent of open area that is not encrusted) will be determined at pre-selected loci on the catheter

Secondary Outcome Measures

Name	Time	Method
Incidence of catheter blockage requiring early removal	26 days	Catheters removed prior to completion of treatment regimen will be assessed for each treatment group
Assessment of encrustation of catheter	26 days	Qualitative and quantitative assessment of encrustation of catheter will be determined for all catheters removed
Assessment of biofilm of catheter	26 days	Qualitative and quantitative assessment of biofilm of catheter will be determined for all catheters removed

Trial Locations

Locations (8)

McGuire Veterans Affairs Medical Center; 🇺🇸 Richmond, Virginia, United States

Kessler Institute for Rehabilitation; 🇺🇸 West Orange, New Jersey, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Integrity Medical Research; 🇺🇸 Mountlake Terrace, Washington, United States

Los Amigos Research and Education Institute (LAREI); 🇺🇸 Downey, California, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Specialists in Urology; 🇺🇸 Naples, Florida, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States