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van CCT (UK)

van CCT (UK)

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

- candidate number28609
- NTR NumberNTR7031
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-feb-2018
- Secondary IDsNL62764.018.17 MEC AMC
- Public TitleResearch into effectiveness and costs concerning the use of oestrogen before and after vaginal prolapse surgery in women after menopause.
- Scientific TitleCost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergonig prolapse surgery
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedProlapse, Prolapse surgery, Genital prolapse
- Inclusion criteria- Postmenopausal women (>1 year amenorrhoea) with a minimum age of 18 years old
- Pelvic organ prolapse; POP Quantification stage 2 or higher
- Women that will undergo primary POP surgery with native tissue repair; including at least anterior OR posterior vaginal wall repair
- Exclusion criteria- Previous POP surgery in concerning compartment
- Prolapse repair using mesh
- Current vaginal infection
- Use of oestrogens in the past 12 months
- Contraindication for use of topical oestrogen
- Known, past or suspected oestrogen-dependent malignant tumours (e.g. breast cancer, endometrial cancer);
- Insufficient knowledge or understanding of the Dutch language
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-mrt-2018
- planned closingdate19-jun-2020
- Target number of participants300
- InterventionsIntervention 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).
- Primary outcomeSubjective cure (PGI-I)
- Secondary outcome- Compound measure:
[1] no prolapse in compartment of surgery or past the hymen
[2] no bothersome complaints of prolapse
[3] no re-intervention for prolapse in the compartment of surgery within the follow-up period;
- QALY (EQ-5D-6L);
- Disease specific quality of life: micturition, defecation and sexual function; - Vaginal pH;
- Signs of vaginal atrophy during gynaecological examination;
- Complaints of vaginal atrophy;
- Morbidity and adverse events;
- Interventions for pelvic floor pathology;
- Costs;
- Adherence to treatment.
- TimepointsTimepoint 1: baseline (4-6 weeks preoperative)
Timepoint 2: 3 months postoperative
Timepoint 3: 12 months postoperative
- Trial web
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Leading the Change
- Publications
- Brief summaryWorldwide 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.
- Main changes (audit trail)
- RECORD19-feb-2018 - 12-mrt-2018

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