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

A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency

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.

Study Overview

• Status: Completed
• Conditions: Urinary Catheter Blockage and Encrustation
• Intervention / Treatment: Drug: NVC-422, 0.2%; Drug: Sterile normal saline, 0.9%

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Los Amigos Research and Education Institute (LAREI)
  • Florida
    • Naples, Florida, United States, 34102
      • Specialists in Urology
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Institute for Rehabilitation
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire Veterans Affairs Medical Center
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Integrity Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Drug: Sterile normal saline, 0.9%; Saline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period; Other Names: 0.9% Sodium chloride for injection, USP
Experimental: NVC-422	Drug: NVC-422, 0.2%; 0.2% NVC-422 (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period; Other Names: N,N-dichloro-2,2-dimethyltaurine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NovaBay Pharmaceuticals, Inc.
• Investigators: Study Director: Kenneth D. Krantz, MD, PhD, NovaBay Pharmaceuticals / kkrantz@novabaypharma.com

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Estimate): August 7, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; SCI; Catheter; Blockage; Encrustation
• Other Study ID Numbers: CL1001