Active — Not RecruitingNot Applicable

Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair

Netherlands305 participantsStarted 2023-04-23

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Female patient \>18 years of age
✓. Complaints of pelvic organ prolapse
✓. Indication for prolapse surgery (level I and/or level II repair)
✓. Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm

Exclusion criteria

✕. Unable to understand the Dutch language
✕. Pregnancy at baseline or intendancy to become pregnant during the study period
✕. Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)
✕. Unwilling and / or incapable of giving informed consent

What they're measuring

Surgical success

Timeframe: 12 months

Trial details

NCT IDNCT05713422

SponsorMarjolein Spiering

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials