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

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

Non Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Description

First, the investigators will carry out a small feasibility study with inclusion of 20 patients with pelvic organ prolapse (POP) already using a pessary to check if it is possible to perform adequate measurements of the pelvic floor on transperineal ultrasound with the pessary in situ. By doing this cross-sectional study, the investigators want to refine our technique to optimize data collection.

The study will be designed as a monocentric prospective longitudinal study. Patients presenting to our gynecology outpatient department with symptomatic POP, who choose to try a pessary after thorough counseling, will be recruited. The follow-up will continue for 1 year after the insertion of the pessary. Regular check-ups at 2 weeks, 3, 6, and 12 months will be performed to document patient-reported outcome measures (PROMs), perform a clinical examination. Transperineal ultrasound (TPUS) and uroflowmetry will be added to the examinations at the check-up at 3 and 12 months.

Eligibility

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

Study details
    Pelvic Organ Prolapse

NCT04915664

Universiteit Antwerpen

20 August 2025

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