Pelvic organ prolapse and oestrogen: a feasibility study

This thesis presents a feasibility study to assess the effect of local oestrogen in postmenopausal women undergoing pelvic organ prolapse (POP) surgery (LOTUS study). It stemmed from a Cochrane systematic review by Ismail et al (2010) which identified the dearth of a well organised randomised controlled trial with adequate sample size, validated outcome measures and long term follow up to assess the value of oestrogen in the prevention as well as management of pelvic organ prolapse. This thesis aimed to answer this question. Firstly, a systematic review was performed to ascertain the global prevalence of POP in women in order to understand the burden of disease using epimaps. The review found that the prevalence of symptomatic POP increased with age up to 65-75 years (mean of 35%); thereafter it plateaued. Secondly, another systematic review utilising the COSMIN checklist was carried out in order to determine which validated questionnaire or patient reported outcome measure best captured the subjective outcomes from women with POP. Strong evidence supported internal consistency and construct validity for Pelvic floor distress inventory short form 20 (PFDI sf 20), Pelvic organ prolapse symptom score (POP-SS) and electronic Personal Assessment Questionnaire pelvic floor (ePAQ-PF). Subsequently a feasibility study to assess the effect of local oestrogen in postmenopausal women undergoing pelvic organ prolapse (POP) surgery (LOTUS study) was set up as the first step in a phased approach to performing a large-scale study. The feasibility study concluded that a large multicentre RCT was feasible. In addition, a qualitative study was conducted to understand the factors that motivate these women for, and barriers to recruitment in clinical trials. From the findings of the two systematic reviews, the qualitative study and the feasibility study, a proposal for a robust multi-centric randomised controlled definitive study was designed