Pelvic organ prolapse affects millions of women worldwide and often leads to discomfort, repeated visits to the doctor and a reduced quality of life. Current pessary treatments have limitations, often require multiple adjustments and cause side effects that discourage long-term use.
Our project is developing an innovative pessary that offers comfort by adapting to each individual's unique anatomy, as well as reliability and greater autonomy for women. By integrating patient feedback and clinical expertise, we are creating a solution that improves daily life, reduces the burden on healthcare services and enables women with pelvic organ prolapse to manage their condition more independently.
Objectives
The project focuses on:
- Further developing and optimising Flexsupp into a market-ready medical device.
- Conducting technical verification and clinical validation of the product.
- Obtaining CE marking in accordance with the applicable medical device regulations.
- Improving comfort, ease of use and independence for women with pelvic organ prolapse.
- Breaking the taboo surrounding pelvic floor health.
- Preparing for production, scaling up and market introduction in the Netherlands and Europe.
- Strengthening regional innovation and collaboration between healthcare providers, knowledge institutions and businesses.
Expected outcomes
Through the Flexsupp project, the project partners expect to achieve:
- A technically verified and clinically validated Flexsupp.
- A product design ready for industrial production and scaling up.
- A CE-certified medical device that meets the applicable quality and safety requirements.
- An innovative treatment option that offers women greater autonomy and helps reduce the burden on healthcare services.
- A strong foundation for widespread adoption of the technology in the Netherlands and Europe.
Project partners
- Saturn Pelvic Health (lead partner)
- Radboud University Medical Center
- Zuyderland Medical Centre
European support
This project is made possible in part by financial support from the OPZuid 2021-2027 programme and the European Regional Development Fund (ERDF).
