NL-OMON21781RecruitingNot Applicable
A randomised controlled trial comparing the clinical and cost-effectiveness of the Avaulta anterior mesh and the standard anterior colporraphy for the primary surgical treatment of a cystocele stage ≥ 2
niversity Medical Center Utrecht (UMCU)0 sites115 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 115
Study Overview
Brief Summary
/A
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Women aged 40-80 years
- •2. Cystocele stage ¡Ý 2 according to POP Q classification
Exclusion Criteria
- •1. Women with childbearing potential who do not use adequate contraceptive measures (hormonal contraceptives, barrier methods (condoms), intra uterine device, male vasectomy, sterilisation).
- •2. History of major gynaecological or urological surgery, with the exception of a hysterectomy for reasons other than a genital prolapse.
Investigators
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