In surgical therapy of male stress urinary incontinence a distinction is drawn between fixed and adjustable slings. An example of a fixed sling is the AdVance™. In contrast adjustable slings work by increasing urethral closure pressure (UCP) that can be adjusted to patients’ individual postoperative conditions. The proposed target pressures in the literature after male sling implantation range between 30 and 60 cmH2O. We introduce a novel anchored male continence system with bilateral anchor fixation in the oburator membrane and a central active element that can be filled with sterile water via a connected port. The insertion process is vitally facilitated by avoiding large trocars.

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 device was developed. Pressure adaptation on the bulbar urethra is achieved with a water filled cushion that is integrated in the central part of the sling. The newly developed concave shape of the cushion adapts to the anatomy of the bulbar urethra, in contrast to other adjustable systems, e.g. ATOMS™. The filling process is conducted via a subcutaneous port. Effectivity of the novel adjustable sling system was measured as retrograde leak point pressure (RLPP) in simulated operations in fresh male cadavers. 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.

The implantation process of the novel sling system was easy, quick, safe, and well reproducible in all cases. After refinements of the design of the active element an ideal pressure transmission to 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.

Adjustable male sling systems, primarily designed for patients with moderate to severe post-prostatectomy-incontinence, are available for more than 15 years, giving a good amount of experience. Some unfavorable effects (esp. pain and infection) are related to the size of the implants, particularly after adjustments (filling or tensioning), and to the adjustment site (suprapubic or obturator), yielding improvements. The novel design and implantation process of the featured sling system provides a better adaptation to the male urethral anatomy, particularly after adjustments. The development process of this novel device was very much oriented not only to provide an effective but also a gentle procedure for this cohort of mostly elderly patients.

With the 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 of urethral closure pressure and continence status has to be further investigated in clinical studies after device approval.