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Clinical Trials/NL-OMON47134
NL-OMON47134CompletedNot Applicable

Pessary or surgery for symptomatic pelvic organ prolapse - PEOPLE - PEssary Or ProLapse surgEry

niversitair Medisch Centrum Utrecht0 sites436 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
436
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Women with a prolapse stage 2 or more.
  • •2. Women with moderate to severe POP symptoms. Moderate to severe POP symptoms is defined as a prolapse domain score > 33 on the validated Dutch version of the Pelvic Floor Distress Inventory (PFDI-20).
  • •3. Women who have had a successful pessary fitting procedure: for the RCT.
  • •4. Written informed consent

Exclusion Criteria

  • •1. Prior urogynaecological (prolapse or incontinence) surgery
  • •2. Probability of future childbearing
  • •3. Insufficient knowledge of the Dutch language
  • •4. Co-morbidity causing increased surgical risks
  • •5. Major psychiatric illness
  • •6. Prior pessary use

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

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