Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergoing prolapse surgery.
Phase 3
Recruiting
- Conditions
- 10029903pelvic organ prolapsefemale genital prolapse10074469
- Registration Number
- NL-OMON55535
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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 <p>Subjective cure (PGI-I) </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Compound measure:<br /><br>[1] no prolapse in compartment of surgery or past the hymen<br /><br>[2] no bothersome complaints of prolapse<br /><br>[3] no re-intervention for prolapse in the compartment of surgery within the<br /><br>follow-up period;<br /><br>- QALY (EQ-5D-6L);<br /><br>- Disease specific quality of life: micturition, defecation and sexual<br /><br>function;<br /><br>- Vaginal pH;<br /><br>- Signs of vaginal atrophy during gynaecological examination;<br /><br>- Complaints of vaginal atrophy;<br /><br>- Morbidity and adverse events;<br /><br>- Interventions for pelvic floor pathology;<br /><br>- Costs;<br /><br>- Adherence to treatment. </p><br>