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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVC-422 | Experimental |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth D. Krantz, MD, PhD | NovaBay Pharmaceuticals / kkrantz@novabaypharma.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Amigos Research and Education Institute (LAREI) | Downey | California | 90242 | United States | ||
| Specialists in Urology |
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| 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 |
|
|
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 |
| Naples |
| Florida |
| 34102 |
| United States |
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | United States |
| Integrity Medical Research | Mountlake Terrace | Washington | 98043 | United States |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C560851 | NVC-422 |
| D012965 | Sodium Chloride |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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