Research into effectiveness and costs concerning the use of (vaginally administered) oestrogen before and after vaginal prolapse surgery, in women after menopause.

Conditions

Pelvic organ prolapse MedDRA version: 21.1 Level: PT Classification code 10046940 Term: Vaginal prolapse System Organ Class: 10038604 - Reproductive system and breast disorders

Vodegel EV, Zwolsman SE, Vollebregt A, Duijnhoven RG, Bosmans JE, Speksnijder L, Roos EJ, Spaans W, Gerards F, Adriaanse A, Vernooij F, Milani AL, Sikkema M, Weemhoff M, Mous M, Damoiseaux A, van Dongen H, V/D Ploeg M, Veen J, van de Pol G, Broekman B, Steures P, Tjin-Asjoe F, van der Stege J, Mouw R, van der Vaart CH, Roovers JWR.

2021-12-314 citations

10.1186/s12905-021-01587-9

Interventions

Trade Name: Synapause Pharmaceutical Form: Vaginal cream Pharmaceutical form of the placebo: Vaginal cream Route of administration of the placebo: Vagin

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Investigate adverse effects and reasons for the discontinuation of treatment.; Primary end point(s): Subjective cure (PGI-I) ; Timepoint(s) of evaluation of this end point: Timepoint 1: baseline (4-6 weeks preoperative) Timepoint 2: 2 months postoperative Timepoint 3: 12 months postoperative ; Main Objective: This study aims to comprehensively compare the effectiveness and costs of perioperative topical oestrogen for postmenopausal women undergoing pirmairy POP surgery. In this trial, the perioperative use of oestrogen is considered superior to placebo which results in cost reduction.	—

Measure

Time frame

Secondary Objective: Investigate adverse effects and reasons for the discontinuation of treatment.; Primary end point(s): Subjective cure (PGI-I) ; Timepoint(s) of evaluation of this end point: Timepoint 1: baseline (4-6 weeks preoperative) Timepoint 2: 2 months postoperative Timepoint 3: 12 months postoperative ; Main Objective: This study aims to comprehensively compare the effectiveness and costs of perioperative topical oestrogen for postmenopausal women undergoing pirmairy POP surgery. In this trial, the perioperative use of oestrogen is considered superior to placebo which results in cost reduction.

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Secondary

Measure	Time frame
Secondary end point(s): - 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. ; Timepoint(s) of evaluation of this end point: Timepoint 1: baseline (4-6 weeks preoperative) Timepoint 2: 2 months postoperative Timepoint 3: 6 months postoperative (adherence to treatment + cost questionnaire only) Timepoint 4: 12 months postoperative	—

Measure

Time frame

Secondary end point(s): - 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. ; Timepoint(s) of evaluation of this end point: Timepoint 1: baseline (4-6 weeks preoperative) Timepoint 2: 2 months postoperative Timepoint 3: 6 months postoperative (adherence to treatment + cost questionnaire only) Timepoint 4: 12 months postoperative

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Countries

Netherlands

Contacts

Public ContactTrial bureau

NVOG Consortium

info@studies-obsgyn.nl0031205663857

Outcome results

None listed