BACKGROUND: Pelvic organ prolapse (POP) negatively affects many women's quality of life. The ability to develop improved therapeutic approaches for POP patients is hampered by low patient recruitment and retention rates in clinical trials.
OBJECTIVE: Our objective was to explore the motivational factors and barriers to recruitment and participation in clinical trials among postmenopausal women with POP who are intending to have surgical management.
DESIGN: Qualitative study based on in-depth face-to-face interviews with postmenopausal women attending urogynaecology clinics in the UK intending to have surgical management for pelvic organ prolapse. These women were eligible to participate in the on-going clinical trial on the use of local vaginal oestrogen as an adjunct to surgical treatment. Twenty-two postmenopausal women aged 52-76 years were interviewed. Interviews were analysed using thematic analysis method.
RESULTS: Many women participated because of altruistic motivations; however, we found that clarity of information provided, timing of approach and acceptability of study design played a pivotal role in women. Of the women who declined participation, the following themes emerged: uncertainty of the investigational product, fear of experimentation, logistical concerns and regret that their condition was trivialised at an early stage.
CONCLUSION: We have gained a valuable insight into women's views and experience in the decision making process. Understanding the elements that will enhance trial participation such as clarity of information provided, balance between professional guidance whilst maintaining equipoise, easy access to trial teams and timing of approach will ultimately enable us to improve our recruitment to clinical trials.