UnknownNot Applicable

Pelvic Ultrasound Pessary Study: Changes in Pelvic Anatomy After Placing a Pessary

Belgium269 participantsStarted 2021-01-01

Plain-language summary

In the past, the impact of pessaries was mostly assessed by questionnaires on Quality of Life (QoL) and sexual dysfunction. This research project primarily aims to objectify the effects of the currently available pessaries in a different way. To accomplish this, the investigators choose transperineal ultrasound and uroflowmetry. Additionally, this project aims to describe the impact of pessaries on the symptoms and QoL.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * symptomatic POP * start of pessary therapy * patient must master Dutch, French or English Exclusion Criteria: * active pelvic infection * severe vaginal ulceration * vaginitis * allergy to silicone and/or latex * non compliant patients * pregnancy

What they're measuring

anatomical changes in the pelvic floor after placement of pessary in midsagittal view

Timeframe: 1/1/2025

What changes in QoL are reported by patients?

Timeframe: 1/1/2025

What changes in micturition and sexual function are reported by patients?

Timeframe: 1/1/2025

Trial details

NCT IDNCT04915664

SponsorUniversiteit Antwerpen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

Contact for this trial

Jolien Govaerts, MD

003238214056 jolien.govaerts@uza.be

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials