As part of the developing process, the obturator region was extensively studied and measured in male cadavers to determine the optimal area for anchor insertion. For this also a new inserter was developed. Pressure adaptation on the bulbar urethra is achieved with a water-filled cushion that is integrated into the central part of the sling. The filling process is conducted via a subcutaneous port. Effectivity of the novel adjustable sling system was measured in simulated operations in fresh male cadavers as retrograde leak point pressure (RLPP). Four series of measurement were conducted after sling insertion, sling tensioning, final sling fixation, and wound closure, respectively. The active element was filled in steps of 1 mL to a maximum of 20 mL and the RLPP measured in cmH2O.
He reported that the implantation process of the novel sling system was easy, quick, safe, and well reproducible in all cases. After technical refinements of the active element, an ideal pressure transmission on the bulbar urethra was achieved with homogeneous pressure slopes. The closure pressures exceeded 30 cmH2O at filling volumes below 10 mL. In some series, the pressure ultimately reached 100 cmH2O as an indicator of the stability and effectiveness of the sling system.
He concluded that this novel adjustable male sling system the urethral closure pressure can be effectively regulated as a function of the filling volume of an active element. The relationship between the urethral closure pressure and the continence status has to be further investigated in clinical studies after device approval.
Presented by: Ralf Anding, MD, Clinic and Polyclinic for Urology and Pediatric Urology, Department of Urology, University Hospital, Bonn, Germany
Written by: Bilal Farhan, MD, Assistant Professor, Division of Urology, University of Texas, Medical Branch, Texas; Twitter: @BilalfarhanMD, at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, SUFU 2020, February 25 - 29, 2020, Scottsdale, AZ