Initial Results with an Absorbable Urologic Scaffold to Mitigate Early Urinary Incontinence Following Radical Prostatectomy: The ARID Study
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Purpose
Stress urinary incontinence (SUI) is a frequent adverse effect following robot-assisted radical prostatectomy (RARP) for prostate cancer. Causes include urethra shortening, bladder neck widening and diminished urethral support. To address these, an implantable, absorbable urologic scaffold has been developed to elongate the urethra and to provide radial support to the bladder neck and urethral stump, at the time of RARP.
Methods
Prospective, non-randomized, single-arm study with the urologic scaffold placed at the time of RARP anastomosis. Endpoints include continence rate at differing timepoints up to 6 months and adverse event rate. Continence was rigorously defined as return to pre-surgery pad weight, inclusive of measurement error, using 24-hour pad weight testing.
Results
Twenty-four subjects with a mean age of 62.9±7.4 years and BMI of 27.1±3.5 were enrolled. Half of the subjects were continent upon catheter removal with 52.2% and 76.2% being continent at 6 weeks and 6 months based on 24-hour pad weight testing. Sub-optimal device placement was determined by video review in some subjects. A sub-analysis was performed which showed 80.0% and 92.9% continence rates at 6 weeks and 6 months for subjects with correctly placed devices compared to 0% and 42.9% when sub-optimally placed. No device-related adverse events were reported.
Conclusion
Early experience with an absorbable urologic scaffold demonstrates the device is safe and reduces SUI following RARP with proper placement associated with improved outcomes Longer term results from this study and an ongoing randomized controlled trial will further define the device’s role towards reducing SUI after RARP.
