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AUA2022: BEST POSTERS Comparative Urodynamic Study in Cadaver of Urethral Pressure Profilometry Between the UroActive Artificial Urinary Sphincter and the AMS800

By: Aurelien Beaugerie, MD; Florence Poinard, MD; Anne Denormandie, MD; Juliette Cotte, MD; Caroline Plassais, MD; Christine Reus, MD, PhD; Emmanuel Chartier-Kastler, MD, PhD, FEBU; Pierre Mozer, MD, PhD | Posted on: 01 Nov 2022

The artificial urinary sphincter (AUS) is currently the gold standard treatment for severe stress urinary incontinence in men. It is also a treatment option for women in Europe, especially in case of suburethral sling failure.1 The most widely implanted AUS in Europe and the United States is the AMS800. This device is a passive hydraulic device and the urethral occlusion pressure is transmitted by the pressure regulating balloon (PRB). PRB pressure is a fixed (usually 61-70 cm H2O as a consensus-validated value2) and cannot be adjusted after implantation. The clinical efficacy of the device has been widely proved in both men3,4 and women,5,6 although with a significant rate of revision and explantation.

UroMems is developing a new AUS named UroActive. It is an active implantable electronic device consisting of an occlusive cuff (OC) connected to an active unit named the “control unit” (CU). As with the AMS800, the OC is placed around the bulbar urethra in men and around the bladder neck in women. In contrast, the CU is placed in the abdomen, above the rectus aponeurosis, so no intra-abdominal surgery is required (Figure 1). The CU contains a pump controlled by an embedded electronic board that can communicate wirelessly with an external programmer and a patient remote control. It is therefore possible for the physician to set device parameters remotely with the external programmer, including to apply occlusive pressure, even after implantation and for the patient to void using the patient remote control. Features such as lowering the pressure when lying down and automatic deactivation after a certain time of nonopening of the sphincter will be implemented to increase the safety of the device.

Figure 1. Implantation.

The objective of this preclinical study, conducted from February to April 2019 at the surgical and anatomical laboratory of the Assistance Publique–Hôpitaux de Paris (Paris, France) on 6 cadavers, was to assess on cadavers the urethral occlusion pressures covered by UroActive compared to those of the AMS800 and its PRB.

Each subject, 3 male and 3 female, was implanted with an AMS800 OC that was positioned around the bulbar urethra by perineal approach in males, and around the bladder neck by suprapubic laparotomy in females. The OC was connected successively to the 3 different PRBs of the AMS800: 51-60 cm H2O, 61-70 cm H2O, and 71-80 cm H2O. For each PRB, a urethral profilometry was performed with a Goby urodynamic station. AMS PRB was then replaced by the UroActive CU. After calibration of the device, urethral profilometries were performed with set pressures in the device ranging from 10 to 150 cm H2O, by steps of 10 cm H2O.

The primary end point used for the comparative study between AMS 800 and UroActive was maximum urethral closure pressure (MUCP), defined by the highest pressure measured during urethral profilometry. Then, especially to assess the UroActive device, a study correlation was performed between CU set pressure and MUCP.

Figure 2. Maximum urethral closure pressure (MUCP). CU indicates control unit; PRB, pressure regulating balloon.

With the AMS800 PRB, the mean MUCP was 58 IC95%[53; 62] cm H2O, 66 [65; 68] cm H2O, and 76 [70; 81] cm H2O for PRB of 51-60 cm H2O, 61-70 cm H2O, and 66 cm H2O, respectively. With the UroActive CU, the mean MUCP ranged from 23 IC95%[16; 30] cm H2O to 120 [108; 131] cm H2O for set pressures in the CU ranging from 10 cm H2O to 150 cm H2O, respectively. These results are represented in Figure 2. There was a significant correlation between the UroActive CU set pressure and the MUCP (r = 0.99 for males and r = 0.97 for females).

This study shows that the range of urethral occlusion pressures that can be obtained with UroActive covers those obtained with the different PRB of the AMS800. The new UroActive sphincter, which allows one to change device pressure settings remotely, opens the way to personalize patient therapy by adjusting pressures even once implanted. It would thus be possible to look for the minimum urethral occlusion pressure sufficient for the optimal efficacy in terms of continence after device activation, and increase the pressure in case of urinary recurrence.

Significant preclinical studies were already performed on large animals and a pilot clinical trial is planned.

  1. Burkhard FC, Bosch JLHR, Cruz F, et al. EAU guidelines on urinary incontinence in adults. 2020. Available at http://uroweb.org/eau-guidelines/discontinued-topics/urinary-incontinence.
  2. Biardeau X, Aharony S, Campeau L, Corcos J. Artificial urinary sphincter: report of the 2015 Consensus Conference. Neurourol Urodyn. 2016;35(suppl 2):S8-S24.
  3. Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Eur Urol. 2013;63(4):681-689.
  4. Linder BJ, Rivera ME, Ziegelmann MJ, Elliott DS. Long-term outcomes following artificial urinary sphincter placement: an analysis of 1082 cases at Mayo Clinic. Urology. 2015;86(3):602-607.
  5. Phé V, Benadiba S, Rouprêt M, Granger B, Richard F, Chartier-Kastler E. Long-term functional outcomes after implantation of artificial urinary sphincter in women suffering from stress urinary incontinence. BJU Int. 2014;113(6):961-967.
  6. Reus CR, Phé V, Dechartres A, Grilo NR, Chartier-Kastler E, Mozer PC. Performance and safety of the artificial urinary sphincter (AMS 800) for non-neurogenic women with urinary incontinence secondary to intrinsic sphincter deficiency: a systematic review. Eur Urol Focus. 2020;6(2):327-338.

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