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Clinical Trials/DRKS00032443
DRKS00032443
Recruiting
Not Applicable

Prospective observational study to evaluate the efficacy and safety of laparoscopic bilateral uterosacropexy with DynaMesh®-CESA and VASA mesh implants in women with pelvic organ prolapse - Pro-USA-AWB

Frauenklinik der Universität zu Köln0 sites163 target enrollmentAugust 8, 2023
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ConditionsN81.2Incomplete uterovaginal prolapse

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
N81.2
Sponsor
Frauenklinik der Universität zu Köln
Enrollment
163
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 8, 2023
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Frauenklinik der Universität zu Köln

Eligibility Criteria

Inclusion Criteria

  • •Impaired by pelvic organ prolaps symptoms \>4 (according to the Numerical Rating Scale (NRS) score from 0\-10, where 0 \= not affected to 10 \= severely affected)
  • •Signed declaration of consent including authorization for data processing
  • •Women of childbearing potential with adequate contraceptive protection. Safe contraceptive measures are considered (Pearl Index \< 1%):

Exclusion Criteria

  • •Serious, life\-threatening and/or active malignancy
  • •Congenital uterine anomalies
  • •Conspicuous PAP smears or evidence of CIN II/III or unexplained postmenopausal bleeding
  • •Surgical pre\-treatment for descensus uteri
  • •Existing or planned pregnancy: In patients of childbearing age, pregnancy must be ruled out by means of a pregnancy test or other suitable methods.

Outcomes

Primary Outcomes

Not specified

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