Original Article

Femicushion™: a new pessary generation - pilot study for safety and efficacy

  • SOPHIA SOUTO
  • THAIS PALMA
  • PAULO PALMA

Pelviperineology 2016;35(2):44-48

Introduction and Objective:

Pelvic Organ Prolapse (POP) is a condition related to loss of anatomical support of pelvic organs. A non-invasive treatment option is a pessary, intravaginal device that provides anatomical support. Femicushion™ is a device that works as an external pessary and was developed for easier placement and reduction of complications that might happen from pessary use. Our aim is to assess the efficacy of Femicushion™ in the vaginal symptoms caused by prolapse and their impact in Quality of Life.

Patients and method:

We evaluated five women with symptomatic POP. The ICIQ-VS questionnaire was chosen for assessment of symptoms and Quality of Life impact caused by the prolapse. Patients were assessed at baseline and received the device and required use orientations. Femicushion™ was used for three months and patients were re-assessed after this period.

Results:

We observed a decrease in the ICIQ-VS score with the use of Femicushion™. The greatest differences were observed in question 1 (pain in lower abdomen), question 5 (lump or bulge presence) and question 6 (visual lump or bulge outside the vagina). After a period of three months of Femicushion use, we observed improvement in the vaginal symptoms and in the impact they cause in the Quality of Life of the patients.

Conclusion:

Femicushion™ was effective in the reduction of symptoms and impact in Quality of Life caused by pelvic organ prolapse.

Keywords: Pessary; Femicushion™; Prolapse.