NCT04915664

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

Pelvic Ultrasound Pessary Study: a Prospective Study for the Development of an Innovative Personalized Approach

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 269 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Pessary	Use of Pessary as treatment of POP

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2021-06-07
• Last updated: 2021-06-07

Locations

1 site across 1 country: Belgium