New thesis: Rethinking the artificial urinary sphincter : from current knowledge to the development of a new smart device

What's the main focus of your thesis?

This thesis focuses on the development of a novel electronic urinary sphincter device for the surgical treatment of severe stress urinary incontinence (SUI) secondary to intrinsic sphincter deficiency (ISD) in both genders. We rethink the current ‘Gold Standard’, the AMS 800Ô artificial urinary sphincter (AUS), from today’s literature perspective to the design of a new smart device, leading to pre-clinical studies and finally to its final version prior to its use in First in Man (FIM) clinical trials.

Which are the most important results?

Our studies showed that the level of evidence for AUS procedure in non-neurogenic adult women suffering from severe refractory SUI due to ISD is very low, and that further well-designed studies are required. It is also important to develop more standardized evaluation tools for urinary incontinence outcomes after AUS implantation in patients with urine leakage following prostate surgery to decrease heterogeneity in published data across studies. Thanks to prospective in vivo clinical testing determining the exact volume the AMS 800Ô could accommodate, we enabled engineers to dimension the novel electronic device. Furthermore, we confirmed its ease of implantation and demonstrated it provided similar maximum urethral closure pressure (MUCP) performance equivalent to the AMS 800Ô. Finally, we ascertained the novel device’s feasibility of implantation and histopathological safety in an animal pilot study. We can now safely consider a larger Pivot study, prior to proceeding to the First in Man (FIM)Trials.

How can this new knowledge contribute to the improvement of people’s health?

Our research contributes to patient health improvement as follows:

• We raise awareness on the need for better conducted clinical studies to improve the quality of reported long-term functional, qualitative, and device survival outcomes. We recommend that AUS surgery should be reserved to well-selected women and conducted in highly specialized, high-volume centers to ensure patient safety.
• We encourage the use of 24-h Pad weight test as an outcome evaluation tool in post-AUS surgery to decrease heterogeneity in published data. Launching national patient registries for UI implant surgery could improve data collection, post-market evaluation, and patient post-operative safety.
• In bridging the gap on transscrotal AUS implantation knowledge, our results are particularly relevant for pre-operative patient counseling and expectation management.
• The development of a novel electronic device, in line with current EU and USA regulations aims to improve patient SUI management by striving to offer a functional, easy implantable, safe, and efficient alternative treatment to patients with refractory severe SUI.

What are your future ambitions?

From a research perspective, I hope to participate in the multicentric FIM trial, evaluating the implantation of the new smart urinary sphincter device. I wish to continue expanding the research portfolio of my department, specifically in active implantable medical devices, focusing on reported performance, safety and qualitative outcomes improvement. I will also perfect my sub-specialist surgical skills. Finally, I shall strive to grow as a clinician and human being, serving/helping my patients to the best of my ability.

Dissertation

Friday June 3, 2022 at 09:00, Rolf Luft Auditorium, L1:00, Karolinska University Hospital Solna

Thesis

Rethinking the artificial urinary sphincter : from current knowledge to the development of a new smart device