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).
1. Female, ≥ 18 years of age
All women of childbearing potential must have a negative urine pregnancy test result documented prior to inclusion into the trial at Screening.
SUI or stress predominant mixed urinary incontinence due to intrinsic sphincter deficiency (ISD) for at least 6 months
Failed conservative therapy for stress urinary incontinence
1. Urgency Predominant Mixed urinary incontinence, confirmed by 3-day bladder diary. (greater than 50% of incontinence episodes due to urge or less than 50% of incontinence episodes due to stress).
Negative cough test or lack of leakage with valsalva maneuver on physical exam
Historical Detrusor overactivity as determined by urodynamic assessment within the past year
Significant urethral hypermobility (e.g. vaginal swab > 30° from horizontal bladder neck)
Parallel
NASHA Dx
DeviceThe 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
DeviceBulkamid 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.
Primary Effectiveness Endpoint
At least a 50% reduction from baseline to 12 months post-treatment in urine leakage, as documented by the 24-hour pad weight test.
Primary Safety Endpoint
The incidence of all adverse events (AEs) through the 12-month follow-up visit after the final injection.
Proportion of subjects with at least a 50% reduction from baseline in daily number of incontinence episodes
Documented via bladder diary
Change from baseline in Urogenital Distress Inventory-Short Form (UDI-6) score
UDI-6 is a validated 6 item questionnaire that evaluates three main symptom categories: irritative (urgency/frequency), stress (activity related leakage), and obstructive/discomfort (voiding difficulties and pain).
Change from baseline in Incontinence Impact Questionnaire, Short Form (UIQ-7) score
UIQ-7 is medical assessment tool that measures how urinary incontinence affects quality of life and daily activities.
Patient Global Impressions Improvement (PGI-I) responder rate
Based on the subject perception of effectiveness ("somewhat improved," "much improved" or "very much improved")
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