Initial results with an absorbable urologic scaffold to mitigate early urinary incontinence following radical prostatectomy: the ARID study

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. An implantable, absorbable urologic scaffold has been developed to elongate the urethra and provide radial support to the bladder neck and urethral stump, at the time of RARP. METHODS: Prospective, non-randomized, single-arm early feasibility study with the urologic scaffold placed during RARP. While not sufficiently powered, endpoints were device safety and continence rate at differing timepoints up to 6 months. 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. No device-related adverse events were reported. 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. A sub-analysis of subjects with sub-optimally placed device confirmed by video review 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. CONCLUSION: Early experience from a first-in-human with an absorbable urologic scaffold demonstrated no adverse events associated with the device. Observed patient outcomes suggest that the device reduces SUI following RARP when properly placed. Longer term results from this study and an ongoing randomized controlled trial will further define the device's role in reducing SUI after RARP. CLINICAL TRIAL REGISTRATION NUMBER: NCT06275945.