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Completed

NCT Number: NCT01243125

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

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.

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Key information

Conditions

Urinary Catheter Blockage and Encrustation Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NVC-422, 0.2%

Drug

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

Sterile normal saline, 0.9%

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NovaBay Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 18, 2010
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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