Study design and participants

The PEOPLE project was initiated to compare the effectiveness of pessary and surgery in women with symptomatic POP, and includes a non‐inferiority randomised controlled trial (RCT) and this observational cohort study. While recruitment for the RCT was continuing, many women expressed strong preferences in treatment choice and, as a consequence, refused to participate in the RCT. Therefore, we set up this observational cohort alongside the RCT. This study was performed in 22 Dutch hospitals. The project was funded by ZonMw, a Dutch organisation for innovation and research in health care and was approved by the Medical Ethical Committee of the University Medical Centre Utrecht (UMCU).

We included women who were referred by their general practitioner (GP) with POP stage ≥2 according to the International Continence Society (ICS) POP‐Q system and moderate to severe POP symptoms, defined as a prolapse domain score of >33 on the original Urinary Distress Inventory. ²⁵ Exclusion criteria were prior prolapse or incontinence surgery, probability of future childbearing, insufficient knowledge of the Dutch language, comorbidity causing increased surgical risks, major psychiatric illness and prior pessary use.

Women were counselled by their gynaecologist about pessary and surgical treatment according to the Dutch guidelines. ²⁶ After a week, all women were asked if they were willing to participate in the RCT. If a woman actively opted for one these treatments she was invited for follow‐up in this observational cohort. A follow‐up at 6 weeks, 12 months and 24 months was planned as part of the study protocol, and women were instructed to return to the hospital if they experienced any complaint. If self‐management of a pessary was not possible or not preferred, women were seen at 4‐month intervals for pessary cleaning and vaginal inspection. If women performed self‐management, the frequency of cleaning was left to their personal judgement but was advised to be no less frequently than every 4 months.

Patient data were collected in an electronic case report form (openclinica 3.6; OpenClinica, LLC, Waltham, MA, USA). limesurvey 2.6.7 (forums.limesurvey.org) was used to digitally send out questionnaires and store the responses. All patients gave written informed consent.