Self-management of vaginal pessaries for pelvic organ prolapse: multi-method process evaluation, linked to the TOPSY...

Pelvic organ prolapse negatively affects women's quality of life globally. Vaginal pessaries are a common first-line treatment. The evidence base to support pessary self-management and to understand how it affects women's lives is poor. This study aimed to identify the acceptability, effectiveness, fidelity to delivery, and adherence for women treated with vaginal pessary for prolapse and the healthcare professionals who treat them and how these differed between self-management and clinic-based care.

Multi-method process evaluation embedded within a randomised controlled trial in 21 UK secondary care centres. Data were collected using the following: Recordings of self-management support appointments (n = 21) and 2-week post-support follow-up phone calls (n = 34), healthcare professional completed fidelity checklists of self-management support appointments (n = 156) and 2-week follow-up calls (n = 145), interviews with purposively sampled women randomised to each trial group at baseline (n = 36 total) and 18 months (n = 23), interviews with women who declined randomisation to the trial at baseline (n = 20) and 18 months (n = 18), interviews with healthcare professionals (n = 36), and a free-text response question in the trial questionnaire (n = 77 comments at baseline, n = 136 6 months, n = 127 12 months, n = 98 18 months).

Self-management was acceptable with all intervention components perceived as important for women's self-management ability and to how the intervention worked. Women's adherence to self-management and clinic-based care varied. Pessary-related complications negatively influenced adherence in both groups. Emotional labour from healthcare professionals in both types of pessary management was a moderator on the pathway to effectiveness. Women's and healthcare professionals' positive attitudes were central to successful implementation. Self-managing women expressed self-efficacy differently than those who received clinic-based care in that they were more confident in addressing common pessary problems, and their confidence grew over time. Women in the clinic-based care group had confidence but in paternalistic pessary care. Self-management and clinic-based care were delivered differently, and thus, the trial was a true test of the effectiveness of self-management.

This is the first study to provide a programme theory for pessary self-management. Given the acceptability of self-management, the programme theory developed could be used to support the implementation of self-management in clinical practice. Further research is needed to support widespread implementation.

ISRCTN62510577 (date of first recruitment was 16th May 2018).