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Patient specific pessary


Meer dan de helft van de vrouwen boven het 40e levensjaar krijgt te maken met een verzakking van blaas, baarmoeder en/of darm. Vrouwen ondervinden hiervan veel klachten (plassen, poepen, vrijen) en de kwaliteit van leven wordt hierdoor ernstig beïnvloed.
De behandelopties zijn pessariumtherapie of een operatie. Een operatie heeft 30% kans op het terugkeren van een verzakking.
Een pessarium duwt de verzakking omhoog. Helaas past een pessarium niet altijd waardoor het onvoldoende werkt of juist bijwerkingen veroorzaakt. Het overgrote deel van de vrouwen met een pessarium blijft jarenlang regelmatig onder controle bij de huisarts of gynaecoloog omdat ze zelf niet in staat zijn het pessarium te wisselen of schoon te maken. Ongeveer 53% van de vrouwen besluit om deze redenen binnen 5 jaar te stoppen met deze behandeling. Met behulp van deze subsidie willen we een patiënt specifiek pessarium maken. Hierdoor past het beter, kunnen mensen het zelf bedienen en veroorzaakt het minder bijwerkingen.


Samenvatting van de aanvraag

Patient specific pessary treatment for women with pelvic organ prolapse. The project concerns the development and evaluation of a patient specific pessary for women with Pelvic Organ Prolapse (POP). POP is a bothersome condition with a negative impact on women’s social, physical and psychological well-being affecting more than half of adult women above age forty. In the Netherlands there are about 4.7 M females over 40 (Statistics Netherlands). The most common symptoms of POP are a feeling of pelvic pressure (something is falling out of the vagina), low backache, painful intercourse or inability to have intercourse, urinary problems such as involuntary release of urine or a frequent or urgent need to urinate and problems with bowel movements such as constipation. These symptoms of POP can have a great negative impact on women’s social, physical and psychological well-being. In case of symptomatic POP, treatment options include pessary treatment or surgery. Pessaries are used for the treatment of POP by more than 85% of gynaecologists and 98% of urogynaecologists. Pessary therapy in the standard care consists of pessaries which are available in different shapes and sizes. The shapes are often simple and symmetric and do not take the complex shape of the female pelvic bottom into account. Therefore, it is not always possible to find a fitting pessary for women with POP. A fitting pessary should improve the target pelvic floor symptoms, should be comfortable for the patient, should not limit daily activities, should not obstruct voiding or defecation and should not cause vaginal irritation. If a pessary does not properly fit, patients may develop side effects such as blood loss and/or excessive discharge. Furthermore, with the standard pessaries it is often impossible to have sexual intercourse and only a small part of the women with pessary therapy are able to remove/clean and insert the pessary by self-management. Most women find it painful to remove the pessary for fitting or cleaning. The larger part of these women need at least 3-4 doctor visits per year. Patient preference plays a very important role in the willingness to try a pessary. According to a Dutch study showing that 48% of treatment-naive women prefer surgery, 36% prefer pessary treatment and 16% have no preference . Although pessaries have been reported to be effective in reducing prolapse symptoms 20–50% of women discontinue pessary use within 1 year. Side effects have been reported to occur in half of the women and are the main reason for discontinuation. In the last couple of years we did a lot of research concerning the identification of patient specific parameters using MRI, Vaginal tactile imager (VTI), focusgroups, and by doing a lot of physical examinations in women with POP. These research results lead to a package of requirements from which a concept design was developed. We evaluated this concept and it meets a lot of the requirement like fitting, adaptation to patient specific POP en reducing pressure points. We need to further develop the patient friendly requirements an add these developments to this concept to finalise a proof of concept which we can test in test subjects.



Looptijd: 100 %
Looptijd: 100 %
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
Dr. K. Notten
Verantwoordelijke organisatie: