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NCT05713422
Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair
Conditions: Pelvic Organ Prolapse
Sex: Female
Ages: 18 Years – N/A
Enrollment: 288
Sponsor: Marjolein Spiering
Summary
The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.
Eligibility Criteria
Inclusion Criteria:Female patient >18 years of ageComplaints of pelvic organ prolapseIndication for prolapse surgery (level I and/or level II repair)Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cmExclusion Criteria:Unable to understand the Dutch languagePregnancy at baseline or intendancy to become pregnant during the study periodPatients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)Unwilling and / or incapable of giving informed consent
Source: ClinicalTrials.gov (NCT05713422). StuddyBuddy aggregates publicly available trial information.