Research into effectiveness and costs concerning the use of oestrogen before and after vaginal prolapse surgery in women after menopause.

Worldwide 30% of all pelvic organ prolapse (POP) operations are performed for recurrent prolapse. The costs associated with the treatment of recurrent POP are huge, and the burden by the women who encounter recurrent POP has negative impact on quality of life. Oestrogen has a proven beneficial effect on the healing process of the vagina after POP surgery. It is easy to administer, cheap, and easy to obtain. Based on research performed in our institute, it has been shown that vaginal oestrogen in low dosages is very efficient: in women with vaginal atrophy the vaginal wall thickness doubles after 6 weeks of use. There is also evidence that oestrogen improves wound healing, by reducing the inflammatory responses and promoting angiogenesis. Although there is benefit that vaginal oestrogen therapy improves pelvic floor function following POP surgery, and improves healing conditions, there is no comparative study to evaluate whether vaginal oestrogen therapy before and after POP surgery improves outcome. Based on the theoretical background, such study would need to be performed in postmenopausal women as they have low levels of oestrogen. For that reason, we propose a multicentre randomised controlled trial comparing perioperative vaginal oestrogen therapy to placebo in postmenopausal women undergoing POP surgery. Based on our own research, data in literature, and theoretical background, the reduction in recurrent POP surgery is expected to be 15% or more, which would implicate a cost-saving of 5.1 million euros per year in the Netherlands.

This study aims to comprehensively compare the effectiveness and costs of perioperative topical oestriol for postmenopausal women undergoing POP surgery. In this trial, the perioperative use of oestriol is considered superior to placebo which would result in reduction of recurrence risk of vaginal prolapse with secondary cost reduction.

Timepoint 1: baseline (4-6 weeks preoperative)
Timepoint 2: 3 months postoperative
Timepoint 3: 12 months postoperative

Intervention group:
The intervention group receives 0,5 mg oestriol cream (1mg/g, topical administration) 4-6 weeks preoperative till 12 months
postoperative. (First 2 weeks 0,5 mg once a day, thereafter 0,5 mg twice per week).

Control group:
The other group receives a placebo cream (equal schedule as intervention group).