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This scoping review has been prompted by the author’s clinical and research experience of providing pessary care, teaching women how to self-manage their pessary and recruiting women to a study exploring pessary self-management. When women question aspects of pessary self-management such as the potential risks and benefits, and required frequency of self-care and follow-up, it highlights the lack of evidence required to answer these questions. This scoping review therefore aims to map all available evidence about the subject of pessary self-management to identify the available evidence and knowledge gaps providing the basis for future research. The following research questions were formulated: What is known from the literature about pessary self-management?

Pelvic organ prolapse (POP) can be effectively managed using a pessary. A scoping review found that pessary self-management appears to benefit women with no increased risk. Despite this, many are unwilling to self-manage their pessary. At present there is a lack of understanding about what affects willingness to self-manage a pessary. However, there may be relevant, transferable findings from other literature about barriers to the self-management of other chronic conditions. Therefore, this systematic review aims to identify, appraise and synthesise the findings of published qualitative research exploring the barriers and facilitators to self-management of chronic conditions reported by women.

Background: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. Methods: This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. Discussion: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness. Trial registration: ISRCTN Registry ISRCTN62510577. Registered on June 10, 2017.

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.