Pelvic Ultrasound Pessary Study: Changes in Pelvic Anatomy After Placing a Pessary (PUPS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Pessary

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.

• Study Type: Observational
• Enrollment (Anticipated): 269

Contacts and Locations

• Study Contact: Name: Jolien Govaerts, MD; Phone Number: 003238214056; Email: jolien.govaerts@uza.be
• Study Contact Backup: Name: Yves Jacquemyn, MD; PhD; Phone Number: 003238214056

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • University Hospital Antwerp
      • Contact: EM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anatomical changes in the pelvic floor after placement of pessary in midsagittal view	Anatomy of the pelvic floor will be assessed using 3D/4D ultrasound with the patient in a supine (or standing) position. Pelvic organ descent will be assessed in the midsagittal view on ultrasound, documenting: bladder neck descent (mm), bladder descent (mm), uterine/vault descent (mm), rectal ampulla descent (mm), rectocoele depth (mm). Measurements before and after pessary placement will be compared for each patient.	1/1/2025
What changes in QoL are reported by patients?	The investigators aim to evaluate improvements in POP-related symptoms and the Quality of Life (QoL) This will be measured by using the Pelvic Floor Distress Inventory (PFDI-20). Patients will be asked to fill out these questionnaires at the start of the treatment and at 3 and 12 months.	1/1/2025
What changes in micturition and sexual function are reported by patients?	The investigators aim to evaluate improvements in POP-related symptoms, micturition, and sexual functions. This will be measured by using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Patients will be asked to fill out these questionnaires at the start of the treatment and at 3 and 12 months.	1/1/2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does levator avulsion influence the success of pessary use?	The functional anatomy of the pelvic floor will be assessed using 3D/4D ultrasound with the patient in a supine (or standing) position. 3/4D volumes in the axial plane will be rendered to assess levator ani muscle integrity (intact/partial/complete avulsion). Levator integrity will be assessed on eight tomographic ultrasound images in the axial plane with a slice interval of 2.5 mm. Complete levator avulsion is diagnosed if three central slices show an abnormal muscle insertion. The failure to retain the pessary or changes of pessary size will be registered in the patient's file.	1/1/2025
Is it possible to choose the best fitting pessary based on the measurements obtained by transperineal ultrasound?	The functional anatomy of the pelvic floor will be assessed using 3D/4D ultrasound with the patient in a supine (or standing) position. 3/4D volumes in the axial plane will be rendered to assess the levator hiatus area (HA; cm2), and levator hiatal ballooning at rest, during Valsalva maneuvers and during a pelvic floor muscle contraction. The size of the pessary (mm) will be compared with the obtained measurements of the ultrasound.	1/1/2025
Does the use of a pessary changes the voiding time?	Uroflowmetry data will register voiding time(s) with and without a pessary in place. This will be compared for each patient at baseline and after 3 and 12 months.	1/1/2025
Does the use of a pessary changes flow rate during voiding?	Uroflowmetry curve data will register Qmax (ml/s) and average flow rate (Qave; ml/s).	1/1/2025

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Investigators: Principal Investigator: Yves Jacquemyn, MD; PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (ACTUAL): June 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pessaries, POP, Transperineal Ultrasound
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: EDGE 000855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No