Palette Life Sciences, Inc.
Prospective, randomized, single-blind study to evaluate the safety and efficacy of NASHA Dx investigational device compared to controlled device Bulkamid in adult women with mild, moderate and intrinsic sphincter deficiency (ISD).
This is a prospective, randomized, single-blind study. The primary cohort for this study is adult women with mild, moderate and intrinsic sphincter deficiency (ISD) stress or stress urinary incontinence (SUI) or stress predominant mixed incontinence (MUI). After preliminary screening, subjects who sign an informed consent and are enrolled in the study will be randomized to the Investigational device (NASHA Dx) group or the Control device (Bulkamid) group. Subjects will not be told which treatment they will receive.
Inclusion Criteria: 1. 1\. Female, ≥ 18 years of age 2. All women of childbearing potential must have a negative urine pregnancy test result documented prior to inclusion into the trial at Screening. 3. SUI or stress predominant mixed urinary incontinence due to intrinsic sphincter deficiency (ISD) for at least 6 months 4. Failed conservative therapy for stress urinary incontinence 5. Documentation of at least 3 stress urinary incontinence episodes measured over 3 days 6. Baseline 24-hr. pad weight test ≥ 5 g 7. Intrinsic sphincter deficiency stress urinary incontinence defined as a urodynami…
The NASHA Dx Urethral Bulking System comprises three components; NASHA Dx SUI Injectable Gel, the NASHA Dx SUI Needle and the Uro-BK Delivery Device. NASHA Dx Injectable Gel is a sterile, injectable bulking agent composed of microspheres of cross-linked dextran ("dextranomer," 50 mg/ml) suspended in a carrier gel of non-animal, stabilized hyaluronic acid (NASHA, 17 mg/ml). The dextranomer microspheres range in diameter from 80 to 250 microns (average diameter approximately 130 microns). NASHA Dx Injectable Gel is provided in a pre-filled single use, 1 ml syringe. The syringe is equipped with a tip cap, plunger, and plunger rod. The syringe is terminally sterilized. The injection needle to be used is the NASHA Dx SUI Needle, a 12cm, 23G extra-thin wall stainless steel cannula with markings at 1 cm and 2 cm from the tip, attached to a styrene-butadiene copolymer Luer-lock hub.
Bulkamid Urethral Bulking System (i.e., "Bulkamid") is a permanently implanted, non-resorbable, injectable, transparent, hydrogel for urethral bulking. Bulkamid hydrogel consists of cross-linked polyacrylamide (2.5% w/w) and water (97.5% w/w), which is supplied sterile in 1 ml pre-filled syringes. It is intended to be injected with the sterile 23G x 12cm needle using a Bulkamid Rotatable Sheath. Bulkamid is a commercially available device (P170023) indicated for urethral injection for the treatment of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) due to intrinsic sphincter deficiency (ISD). Instructions for use provided by the manufacturer should be consulted for warnings/precautions, known potential risks, and injection procedure. Bulkamid was selected as the control device for this study because it is the market leader in injectable urethral bulking agents, and hence is the standard of care in the US.