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

NovaBay Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Urinary Catheter Blockage and Encrustation

Treatments: Drug: NVC-422, 0.2%; Drug: Sterile normal saline, 0.9%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243125

CL1001

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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67 participants in 2 patient groups, including a placebo group

NVC-422

Experimental group

Treatment:

Drug: NVC-422, 0.2%

Saline

Placebo Comparator group

Treatment:

Drug: Sterile normal saline, 0.9%