Stress urinary incontinence (SUI) is a common yet often undertreated condition. While several treatment options exist for moderate SUI, women with severe incontinence-particularly due to intrinsic sphincter deficiency (ISD) or a fixed urethra-often have limited effective options after failed procedures. The artificial urinary sphincter (AUS) is the gold standard for severe incontinence in men, but its use in women remains limited due to surgical complexity, higher complication rates, and restricted availability to specialized centers. Consequently, high-quality evidence supporting its use in women is lacking. The VENUS registry aims to address this gap by collecting prospective, standardized data across multiple European centers.
This is a prospective, non-controlled cohort study evaluating outcomes of AUS implantation in female patients using various surgical approaches (robot-assisted, laparoscopic, open, or other). Data will be collected across European centers (NCT04114266). The primary outcome is the cure rate of AUS implantation for female SUI due to ISD. Secondary outcomes include patient-reported outcomes, urodynamic and uroflowmetric changes, postoperative complications, and revision-free survival. The study aims to recruit 150 patients with a follow-up of 5 years.
The VENUS registry will provide real-world evidence on the safety and efficacy of AUS in women. Its findings may support broader adoption and future trials, while identifying clinical and surgical factors associated with successful outcomes, ultimately improving care for women with severe SUI.
The French journal of urology. 2026 Jun 09 [Epub ahead of print]
Marie-Hélène Vinckier, Benoît Peyronnet, Emmanuel Chartier-Kastler, Luis Lopez-Fando, Marie-Aimée Perrouin-Verbeé, Laurent Wagner, Roman Zachoval, Karl-Dietrich Sievert, Gilles Karsenty, Wim Witjes, Xavier Biardeau, Grégoire Capon, Nikesh Thiruchelvam, François Hervé, Charles Mazeaud, Paola Calleja Hermosa, Alain Ruffion, Gommert Van Goeveringe, Xavier Gamé, Aurélien Descazeaud, Frank Van der Aa
Department of Urology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium., Department of Urology, Hôpital Pontchaillou, 2 Rue Henri Le Guilloux, 35000 Rennes, France., Department of Urology, Hôpital de la Pitié-Salpêtrière, 47-83 Boulevard de l'Hôpital, 75013 Paris, France., Department of Urology, Hospital Universitario de la Princesa, Calle de Diego de León, 62, 28006 Madrid, Spain., Department of Urology, CHU de Nantes, 1 Place Alexis-Ricordeau, 44093 Nantes, France., Department of Urology, CHU de Nîmes, Place du Professeur Robert Debré, 30029 Nîmes, France., Department of Urology, Thomayer Hospital, Vídeňská 800, 140 59 Praha 4, Czech Republic., Department of Urology, Klinikum Lippe, Röntgenstraße 18, 32756 Detmold, Germany., Department of Urology, Hôpital de la Conception - AP-HM, 147 Boulevard Baille, 13005 Marseille, France., European Association of Urology Research Foundation (EAU RF), Rijnsburgerweg 10, 2333 AA Leiden, The Netherlands., Department of Urology, CHU de Lille, 2 Avenue Oscar Lambret, 59000 Lille, France., Department of Urology, CHU de Bordeaux, Place Amélie Raba-Léon, 33076 Bordeaux, France., Department of Urology, Cambridge University Hospitals NHS Foundation Trust, Hills Rd, Cambridge CB2 0QQ, United Kingdom., Department of Urology, University of Ghent, De Pintelaan 185, 9000 Ghent, Belgium., Department of Urology, University of Nancy, 29 Avenue du Maréchal de Lattre de Tassigny, 54000 Nancy, France., Department of Urology, University of Santander, Av. de Valdecilla, 39008 Santander, Spain., Department of Urology, University of Lyon, 165 Chemin du Grand Revoyet, 69310 Pierre-Bénite, France., Department of Urology, University of Maastricht, P. Debyeplein 1, 6229 HA Maastricht, The Netherlands., Department of Urology, University of Toulouse, Place du Dr Baylac, 31059 Toulouse, France., Department of Urology, University of Limoges, 2 Avenue Martin Luther King, 87042 Limoges, France.