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

Study Overview
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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.

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

Conditions
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Urinary Catheter Blockage and Encrustation

Intervention / Treatment
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* Drug: NVC-422, 0.2%
* Drug: Sterile normal saline, 0.9%


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blockage, Encrustation, Catheter, Spinal Cord Injury, SCI