Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial

Abstract

ObjectiveTo evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery.Design and settingA randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015–August 2016).ParticipantsPostmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.InterventionWomen were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery.Outcome measuresThe main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial.Results325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use.ConclusionsA large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation.Trial registration numberISRCTN46661996.

Does preoperative locally applied estrogen treatment facilitate prolapse‐associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse? A randomised controlled double‐masked, placebo‐controlled, multicentre study

“…Moreover, recently, Verghese et al 28 . performed a pilot study to assess the feasibility of a multicentre RCT comparing estrogen versus no treatment in women undergoing POP surgery and reported good compliance within the study cohort.…”

“…Our data showed that prolapse-specific complaints were not ameliorated by local estrogen treatment, as neither prolapse nor other domain scores (bladder, bowel, sexual function or global pelvic floor score) differed between the intervention and the placebo group. Moreover, recently, Verghese et al 28 performed a pilot study to assess the feasibility of a multicentre RCT comparing estrogen versus no treatment in women undergoing POP surgery and reported good compliance within the study cohort. The authors would like to corroborate this hypothesis as the compliance rate within our study population was also satisfactorily high (176 patients were assessed for eligibility and 120 were randomised, with a retention rate of 86%).…”

“…Moreover, recently, Verghese et al. 28 performed a pilot study to assess the feasibility of a multicentre RCT comparing estrogen versus no treatment in women undergoing POP surgery and reported good compliance within the study cohort. The authors would like to corroborate this hypothesis as the compliance rate within our study population was also satisfactorily high (176 patients were assessed for eligibility and 120 were randomised, with a retention rate of 86%).…”

Hormone therapy for sexual function in perimenopausal and postmenopausal women: a systematic review and meta-analysis update

“…When studies had several groups using the same drug with different route of administration, dose, or treatment duration, these groups were merged in the meta-analysis 40,42,50 . In three studies, the control was no intervention 34,51,53 . All other studies used matching placebos.…”

“…In symptomatic or recently postmenopausal women, estrogen therapy had no effect to small benefit on sexual function composite score with moderate heterogeneity (SMD, 0.17; 95% CI, 0.01 to 0.32; I 2 = 63%; 2,447 participants, 13 studies 32,36,39,41,42,50,51,53,[57][58][59][60][61][62][71][72][73] ; Fig. 2).…”