Extrait

Background and study aims 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 will be to test whether treatment with vaginal oestrogen pessaries, improves prolapse related quality of life after surgery. We also want to see whether surgical complications are reduced and sexual function improved in these patients. Before starting a large study, it's important to rehearse the trial plan in a small feasibility study (treatment v no treatment), to see, for example, how many eligible women could be recruited to the study, how many would be willing to have treatment assigned at random, and how many would stick with the treatment for a specified period of time. This feasibility study will also help calculate the number of patients required for a definitive study, and the resources needed. Who can participate? Postmenopausal women about to undergo surgery for a pelvic organ prolapse and that have not had HRT in the last 12 months. What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 (intervention) are put on a 6 week course of oestradiol (once daily for 2 weeks followed by twice weekly for four weeks) and then again twice weekly from 6-26 weeks after surgery. Those participants in group 2 (control) are not given the oestradiol treatment. All participants are then followed up 12 months after the surgery to assess their quality of life. What are the possible benefits and risks of participating? To date, there has been no robust data on the benefits of pre and postoperative oestrogen treatment in postmenopausal women undergoing POP surgery. A Cochrane review published in 2010 did not find any clear evidence to suggest whether oestrogens help in reducing the symptoms of POP.3 However due to frequent use, it was recommended that adequately powered RCTs with long term follow up is needed to identify benefits or risks. Where is the study run from? University of Birmingham Clinical Trials Unit (UK) When is the study starting and how long is it expected to run for? July 2015 to July 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Mrs Lisa Leighton

Critère d'inclusion

• Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth

Liens

• ictrp
• isrctn