Clinical trial NCT04915664: Pelvic Ultrasound Pessary Study: Changes in Pelvic Anatomy After Placing a Pessary
Official title: Pelvic Ultrasound Pessary Study: a Prospective Study for the Development of an Innovative Personalized Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: Pessaries, POP, Transperineal Ultrasound
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 269
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with symptomatic POP choosing a pessary as a treatment after counseling about all treatments options who present at our gynecology outpatient department

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: anatomical changes in the pelvic floor after placement of pessary in midsagittal view
timeFrame: 1/1/2025
measure: What changes in QoL are reported by patients?
timeFrame: 1/1/2025
measure: What changes in micturition and sexual function are reported by patients?
timeFrame: 1/1/2025
Secondary outcomes:
measure: Does levator avulsion influence the success of pessary use?
timeFrame: 1/1/2025
measure: Is it possible to choose the best fitting pessary based on the measurements obtained by transperineal ultrasound?
timeFrame: 1/1/2025
measure: Does the use of a pessary changes the voiding time?
timeFrame: 1/1/2025
measure: Does the use of a pessary changes flow rate during voiding?
timeFrame: 1/1/2025
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Yves Jacquemyn, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: