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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Urinary Catheter Blockage and Encrustation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NVC-422

Group Type EXPERIMENTAL

NVC-422, 0.2%

Intervention Type 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

Saline

Group Type PLACEBO_COMPARATOR

Sterile normal saline, 0.9%

Intervention Type DRUG

Saline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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N,N-dichloro-2,2-dimethyltaurine 0.9% Sodium chloride for injection, USP

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No