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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01243125
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urinary Catheter Blockage and Encrustation Drug: NVC-422, 0.2% Drug: Sterile normal saline, 0.9% Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency
Study Start Date : November 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: N,N-dichloro-2,2-dimethyltaurine

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 Name: 0.9% Sodium chloride for injection, USP

Primary Outcome Measures :
  1. Catheter patency following treatment [ Time Frame: 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 :
  1. Incidence of catheter blockage requiring early removal [ Time Frame: 26 days ]
    Catheters removed prior to completion of treatment regimen will be assessed for each treatment group

  2. Assessment of biofilm of catheter [ Time Frame: 26 days ]
    Qualitative and quantitative assessment of biofilm of catheter will be determined for all catheters removed

  3. Assessment of encrustation of catheter [ Time Frame: 26 days ]
    Qualitative and quantitative assessment of encrustation of catheter will be determined for all catheters removed

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01243125

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United States, California
Los Amigos Research and Education Institute (LAREI)
Downey, California, United States, 90242
United States, Florida
Specialists in Urology
Naples, Florida, United States, 34102
United States, New Jersey
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
Integrity Medical Research
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
NovaBay Pharmaceuticals, Inc.
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Study Director: Kenneth D. Krantz, MD, PhD NovaBay Pharmaceuticals /
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Responsible Party: NovaBay Pharmaceuticals, Inc. Identifier: NCT01243125    
Other Study ID Numbers: CL1001
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014
Keywords provided by NovaBay Pharmaceuticals, Inc.:
Spinal Cord Injury