For Investigators

Lotus Trial logo

The International Continence Society and International Urogynaecological Association (IUGA) define pelvic organ prolapse (POP) as the downward descent of the pelvic organs, which results in a protrusion of the vagina and/or uterine cervix.  Prolapse may be associated with weakening or atrophy of the genital tract. Oestrogen deficiency secondary to menopause results in weakening of the supporting ligaments of the pelvic organs and the pelvic floor muscles worsening the symptoms of prolapse. . A decrease in oestrogen levels also results in atrophy of the vaginal epithelium, with more parabasal cells and fewer superficial cells seen on cytology. Associated symptoms include vaginal dryness, soreness, dyspareunia, dysuria or urinary urgency.

Oestrogen treatment can be used to reduce thinning of the vaginal and pelvic tissues. This may help to reduce or prevent the symptoms of prolapse, or may be used to make other prolapse treatments work better.

The aim of the feasibility study is to find out if an appropriately powered randomised controlled trial (RCT) can be realistically undertaken. The feasibility study will also allow the research team to identify any barriers to recruitment and compliance, and fine tune study procedures such as data collection and prescription of the study treatments.

The aim of the definitive study would be to test the hypothesis that vaginal oestrogen treatment of postmenopausal women undergoing pelvic floor repair surgery leads to improved patient reported outcomes in relation to urinary, bowel, sexual function and prolapse related quality of life (QoL).