Polyvinyl chloride ring pessary versus silicon irregular hexagon pessary for pelvic organ prolapse: a randomised trial comparing treatment success

Silicon irregular hexagonal pessary is a non surgical device used for conservative management of pelvic organ prolapse. Participants meeting the study inclusion criteria will be given the information and consent form. The randomisation process takes place once the subject agreed to participate in the study. The allocation will be concealed in an envelope to prevent selection bias. Once the participants been allocated to particular treatment group, the initial pessary pessary fitting by undertaken by doctors and subsequent appointments for pessary change will be undertaken by nurse specialists at pessary clinic. All participants are required to complete the following questionnaires on the first visit before the pessary fitting. They are: (i) Pelvic Floor Distress Inventory Questionnaires (PFDI-20) to assess the severity of pelvic organ prolapse symptoms and impact on bowel and bladder function; (ii) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires (PISQ-12) to measure sexual function in women with pelvic floor disorders; and (iii) Euro Qol Health Questionnaires (EQ-5D) to assess current health status. These are the recommended questionnaires by the international pelvic floor society, International Consultation on Incontinence (ICI) that have been validated to assess quality of life in women with pelvic floor disorders. After completing the questionnaires, subjects will be fitted with a vaginal pessary. The pessary size will be determined on a ‘best-fit’ basis by the clinician fitting the pessary. Topical vaginal oestrogen therapy (Ovestin 1mg/g or Vagifem 10mcg twice weekly) will be prescribed based on clinician preference from the first visit for post-menopausal subjects unless it is contraindicated such as history of breast cancer. Subjects are recommended to use the vaginal oestrogen therapy as long as the pessary is in place. The continuous daily pessary use and the use of vaginal oestrogen therapy will not be monitored as part of the study. Subjects will be reviewed at 1 week to assess correct pessary size and the nurse specialist will instruct subjects to perform self-care of the pessary. This will include teaching the subjects methods to remove, clean and replace their pessary once a week. Subjects who are unable to comply with the recommended self-care advice will be considered as failure in self-care. However, patients continuing to use pessary for 6 months will still be considered as a treatment success whether or not they are able to achieve self-care. For subjects continuing pessary use, further reviews will be undertaken at 6 and 12 months. At these visits, the existing pessaries will be replaced with the same type of pessary that was used. Any adverse events such as vaginal bleeding, discharge, or odour that might indicate vaginal infection and ulceration that is reported by subjects will be recorded at each follow up visits. Subjects with symptomatic vaginal ulceration will have the pessary left out and will be reviewed after 2 weeks to ensure resolution of the problem before replacing the pessary. Subjects with suspected vaginal infection will have a vaginal swab taken and given an antibiotic prescription for treatment. Subjects will be to self report to the clinic if they have any issues in between visits or if the pessary is expelled at any stage. We have appointed Dr Oliver Daly (Urogynaecologist) to be in Data and Safety Monitoring Committee for this study. However, any serious adverse events will be reported to the Royal Women’s Hospital Ethics Committee and Therapeutic Goods Administration (TGA).