LOTUS
Research type
Research Study
Full title
Local Oestrogen Treatment in Postmenopausal Women Undergoing Pelvic Organ Prolapse Surgery (LOTUS) - Feasibility Study
IRAS ID
137113
Contact name
Sean Jennings
Contact email
Eudract number
2014-000179-18
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Pelvic Organ Prolapse is the bulging or drooping of any pelvic organs (bladder, uterus, bowel) into the vagina. Prolapse is a common gynaecologic condition caused by weakening of the supporting tissues of the pelvic floor. Prolapse operations may include vaginal hysterectomy (removal of the womb vaginally) or pelvic floor repair
(tightening of the front or back wall of the vagina or support the top of vagina).
Hormone (oestrogen) replacement might improve the condition of the vaginal wall and help strengthen the pelvic floor, reducing complications of surgery eg water infections and improving the quality of the surgical repair. Postmenopausal women with vaginal dryness are sometimes treated with oestrogen in the form of tablets
(pessaries) they insert into the vagina. However, it's not known whether vaginal application of oestrogen might reduce complications during operations for prolapse and improve long-term postoperative outcomes. The aim of the LOTUS study would be to establish whether treatment with vaginal oestrogen pessaries, for 6 weeks before
and 52 weeks after prolapse repair surgery, improves prolapse-related quality of life one year following surgery. We would also assess whether surgical complications are reduced and sexual function improved. This will require a clinical trial of several hundred women, half of whom would receive oestrogen and half who would receive no treatment.
Prior to starting a large study, it's important to rehearse the trial plan in a small feasibility study (treatment v no treatment), assessing the number of eligible women, how many would be willing to have treatment assigned at random, and stick with treatment for 52 weeks and how many will complete follow-up questionnaires. This feasibility study will also help calculate the number required for a definitive study, and the resources needed. This information will help ensure that any subsequent large study has the best chance of being successful in addressing its aims.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0092
Date of REC Opinion
28 Apr 2015
REC opinion
Further Information Favourable Opinion