Pelvic Organ ProlapsePUPSNCT04915664
Pelvic Ultrasound Pessary Study: Changes in Pelvic Anatomy After Placing a Pessary
An observational study of Pelvic Organ Prolapse, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Pessary
- Type of treatment
- Medical device
- How many people
- 269 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 1 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- symptomatic POP
- start of pessary therapy
- patient must master Dutch, French or English
Who cannot join
- active pelvic infection
- severe vaginal ulceration
- vaginitis
- allergy to silicone and/or latex
- non compliant patients
- pregnancy
Trial locations and contacts
1 site in 1 country.
Yves Jacquemyn, MD; PhD contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Yves Jacquemyn, Phd, +3238215945, yves.jacquemyn@uza.be
EM
About this study
Official title: 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.
Read the 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
- Being tested
- Pessary
- Keywords
- Pessaries, POP, Transperineal Ultrasound
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PessaryDevice
Use of Pessary as treatment of POP
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1/1/2025
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1/1/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 269 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Yves Jacquemyn, Universiteit Antwerpen
- Investigators
- Yves Jacquemyn, MD; PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915664
- Sponsor's protocol ID
- EDGE 000855
- Acronym
- PUPS
- Status last verified
- May 2021
- First submitted
- 5 Jan 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Ultrasound Pessary Study: a Prospective Study for the Development of an Innovative Personalized Approach
- ClinicalTrials.gov ID
- NCT04915664
- Acronym / sponsor ID
- PUPS / EDGE 000855
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pessaries, POP, Transperineal Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- symptomatic POP
- start of pessary therapy
- patient must master Dutch, French or English
Key exclusion criteria (6 listed)
- active pelvic infection
- severe vaginal ulceration
- vaginitis
- allergy to silicone and/or latex
- non compliant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PessaryUse of Pessary as treatment of POP | Device | – |
Primary outcome
anatomical changes in the pelvic floor after placement of pessary in midsagittal view
Time frame: 1/1/2025
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.
What changes in QoL are reported by patients?
Time frame: 1/1/2025
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.
What changes in micturition and sexual function are reported by patients?
Time frame: 1/1/2025
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.
4 secondary outcomes
Does levator avulsion influence the success of pessary use?
Time frame: 1/1/2025
Is it possible to choose the best fitting pessary based on the measurements obtained by transperineal ultrasound?
Time frame: 1/1/2025
Does the use of a pessary changes the voiding time?
Time frame: 1/1/2025
Does the use of a pessary changes flow rate during voiding?
Time frame: 1/1/2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Jacquemyn, MD; PhD contact
Yves Jacquemyn, MD; PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jolien Govaerts, MD (003238214056, jolien.govaerts@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomical changes in the pelvic floor after placement of pessary in midsagittal view (time frame: 1/1/2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.