PolyPrint Development of polymeric structures via 3D printing for the individual incontinence treatment

Urinary incontinence (UI) is a worldwide problem. Around 30% of women and 10% of men are affected with increasing prevalence at elevated ages. According to Statistik Austria (2016), 5.9% of all Austrians deal with UI. The Österreichische Interdisziplinäre Hochaltrigenstudie revealed that more than one third of the persons surveyed suffered from this chronical disease. Again, the disease was more pronounced in women than men (i.e., 40.5 vs. 25.4%). Stress incontinence is the most common type of UI. It is a result of weakening of the pelvic floor muscles and/or the urethral sphincter and occurs at certain activities, such as laughing or coughing. Women are often affected after pregnancy, vaginal birth or during menopause. Often, men are concerned after prostatectomy. Depending on the severity of the disease, several treatment options are available; i) non-surgical, conservative methods (e.g., pelvic floor exercises), ii) medical treatment, and iii) surgical treatment (e.g., implantation of an artificial urethral sphincter, AUS). Additionally, women have the opportunity to use pessaries that alter the position of the bladder and/or the urethra. Advantageously, pessaries do not need any surgical treatment and can be self-inserted and removed by the patient. However, pessaries are only available in a limited number of size and shape. Thus, they are not applicable to every woman depending on the anatomy, the state of health, and patient acceptability. The application of such mechanically stabilizing systems might also be possible in male patients. Although a surgical management is inevitable, these systems are not associated with drawbacks often observed after AUS implantation (i.e., urethral erosion and atrophy). Consequently, there is a need to broaden the complexity of pessaries - which are currently very simple systems - to make them available to a larger, inhomogeneous patient group. The manufacturing of products with complex structures frequently involves multiple complex processes. 3D printing is a technology that enables the specific production of a 3-dimensional structure in a single process step. Moreover, it allows for the fast and efficient product adaptation following the individual patients requirements. During this project a commercially available 3D printing system is used to manufacture different geometries with the aim to evaluate the systems limitations. In addition to siliastic polymers, which are currently the golden standard to fabricate pessaries, various polymeric carrier materials are tested. Additionally, several functional additives are incorporated to broaden the spectrum regarding size, shape and mechanical characteristics. Importantly, the feasibility to (partially) integrate drugs that were shown to aid UI treatment (e.g., estrogens) is investigated. Thereby, these systems do not only provide mechanically stabilizing effects but also provide tailored drug release. Based on the gathered knowledge, the 3D printing system is adapted and eventually, a concept of an optimized 3D printing system and the corresponding process is elaborated. This builds the basis for the fast and efficient manufacturing of innovative pessaries that are adapted to the individual patients needs. These innovative pessaries do not only adapt the position of the bladder and/or the urethra, but also provide the possibility of simultaneous medical treatment.