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Clinical Trials/NL-OMON21781
NL-OMON21781
Recruiting
Not 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 enrollmentTBD
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Conditionsanterior prolapse surgerycystoceleIn het Nederlands:vaginale prolaps chirurgiecystocele

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
anterior prolapse surgery
Sponsor
niversity Medical Center Utrecht (UMCU)
Enrollment
115
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

/A

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversity Medical Center Utrecht (UMCU)

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.

Outcomes

Primary Outcomes

Not specified

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