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Clinical Trials/NL-OMON21781
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

Sponsor
niversity Medical Center Utrecht (UMCU)

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