Pelvic organ prolapse Prolapse surgery Prolaps Verzakking Prolapschirurgie Prolapsoperatie
Conditions
Interventions
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, thereaf
Sponsors
Academic Medical Center Amsterdam
Eligibility
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
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
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Primary
| Measure | Time frame |
|---|---|
| Subjective cure (PGI-I) | — |
Contacts
Public ContactJan-Paul W.R. Roovers
Amsterdam UMC location AMC
Outcome results
None listed