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.

JCG and MNF report being paid consultants to Levee Medical and also having equity with the company in the form of stock options. The remaining authors report having no conflicts of interest to declare.

Clinical Trial ID: NCT06275945

Funding for the ARID study was provided by Levee Medical, Inc. who was involved with the design of the study and is also responsible for study monitoring, data collection, the statistical analysis and interpretation of the data.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The ARID study protocol was reviewed and approved by the Comite de Bioetica en Investigacion at Pacifica Salud Hospital Punta Pacifica, Panama City, Panama on March 5, 2023. Written informed consent was obtained from each patient enrolled in the study.

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The data that supports the findings reported in this paper is not available publicly due to it containing information that could compromise the privacy of study subjects. The data is available from the corresponding author (J.C.G.) upon reasonable request.