Research into effectiveness and costs concerning the use of oestrogen before and after vaginal prolapse surgery in women after menopause.
Completed
- Conditions
- Pelvic organ prolapse Prolapse surgeryProlapsVerzakkingProlapschirurgieProlapsoperatie
- Registration Number
- NL-OMON28340
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective cure (PGI-I)
- Secondary Outcome Measures
Name Time Method - Compound measure:<br>[1] no prolapse in compartment of surgery or past the hymen<br>[2] no bothersome complaints of prolapse<br>[3] no re-intervention for prolapse in the compartment of surgery within the follow-up period;<br>- QALY (EQ-5D-6L);<br>- Disease specific quality of life: micturition, defecation and sexual function;<br>- Vaginal pH;<br>- Signs of vaginal atrophy during gynaecological examination;<br>- Complaints of vaginal atrophy;<br>- Morbidity and adverse events;<br>- Interventions for pelvic floor pathology;<br>- Costs;<br>- Adherence to treatment.