Pelvic Ultrasound Pessary Study: Changes in Pelvic Anatomy After Placing a Pessary
NCT ID: NCT04915664
Last Updated: 2021-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
269 participants
OBSERVATIONAL
2021-01-01
2025-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Pessary
Use of Pessary as treatment of POP
Eligibility Criteria
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Inclusion Criteria
* start of pessary therapy
* patient must master Dutch, French or English
Exclusion Criteria
* severe vaginal ulceration
* vaginitis
* allergy to silicone and/or latex
* non compliant patients
* pregnancy
18 Years
FEMALE
No
Sponsors
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Universiteit Antwerpen
OTHER
Responsible Party
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Prof Yves Jacquemyn
Professor dr. Yves Jacquemyn
Principal Investigators
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Yves Jacquemyn, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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University Hospital Antwerp
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Yves Jacquemyn, MD; PhD
Role: CONTACT
Facility Contacts
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EM
Role: backup
Other Identifiers
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EDGE 000855
Identifier Type: -
Identifier Source: org_study_id
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