NCT04915664

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

June 7, 2021

Status Verified

May 1, 2021

Enrollment Period

4 years

First QC Date

January 5, 2021

Last Update Submit

May 31, 2021

Conditions

Pelvic Organ Prolapse

Keywords

Pessaries, POP, Transperineal Ultrasound

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Does levator avulsion influence the success of pessary use?

    1/1/2025

  • Is it possible to choose the best fitting pessary based on the measurements obtained by transperineal ultrasound?

    1/1/2025

  • Does the use of a pessary changes the voiding time?

    1/1/2025

  • Does the use of a pessary changes flow rate during voiding?

    1/1/2025

Interventions

PessaryDEVICE

Use of Pessary as treatment of POP

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • symptomatic POP
  • start of pessary therapy
  • patient must master Dutch, French or English

You may not qualify if:

  • active pelvic infection
  • severe vaginal ulceration
  • vaginitis
  • allergy to silicone and/or latex
  • non compliant patients
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Pessaries

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Yves Jacquemyn, MD; PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolien Govaerts, MD

CONTACT

003238214056jolien.govaerts@uza.be

Yves Jacquemyn, MD; PhD

CONTACT

003238214056

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor dr. Yves Jacquemyn

Study Record Dates

First Submitted

January 5, 2021

First Posted

June 7, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

June 7, 2021

Record last verified: 2021-05

Locations

BE(1)