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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RECRUITING
200 participants
OBSERVATIONAL
2021-09-03
2028-01-31
Brief Summary
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Detailed Description
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The questionnaires that will be used are the PFDI-20 (pelvic floor distress inventory), PFIQ-7 (pelvic floor impact questionnaire), PISQ-9 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) and a custom-made questionnaire to further investigate the behavior towards pessary use of our patients and the adverse effects they are dealing with. The questionnaires will be taken before the treatment has started, 6 weeks post treatment start, one-year post treatment start, two years post treatment start and 5 years post treatment start. A POP-Q (Pelvic Organ Prolapse Quantification) investigation will be performed to estimate the degree of vaginal prolapse before the start of the treatment. Since clinical follow up is not necessarily needed after one year for the women who undergo surgery, their questionnaires will be taken via telephone or e-mail. For women that are being treated with pessaries the investigators will also take our custom-made questionnaire at 4 and 8 months after starting the treatment.
The investigators would like to recruit 100 women for this study, older than 18 years old who have not undergone a previous treatment with a pessary or surgery for vaginal prolapse. Another exclusion criterium are women who still have a child wish and women who have contraindications for surgery. The investigators will also exclude women who don't speak Dutch or women who cannot give a written consent.
The investigators hypothesize that woman being treated with one year of pessary use are overall not having more symptoms than woman that underwent a surgery. The investigators hypothesize that woman being treated with five years of pessary use are overall having less symptoms than woman that underwent a surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pessary
Vaginal prolapse being treated by pessary
vaginal pessary
insertion and follow up of a vaginal pessary
surgery
Vaginal prolapse being treated by surgical repair
Vaginal prolapse surgery
surgery and follow up after vaginal prolapse surgery
Interventions
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vaginal pessary
insertion and follow up of a vaginal pessary
Vaginal prolapse surgery
surgery and follow up after vaginal prolapse surgery
Eligibility Criteria
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Inclusion Criteria
* older than 18 years
Exclusion Criteria
* undergone a previous treatment with a pessary or surgery for vaginal prolapse
* contra-indications for surgery or pessary use
* active or passive child wish
* not able to understand the Dutch language
* not able to give a written consent
18 Years
FEMALE
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Tjalina Hamerlynck
Role: PRINCIPAL_INVESTIGATOR
UZ Gent
Steven Weyers
Role: PRINCIPAL_INVESTIGATOR
UZ Gent
Van Wessel Steffi
Role: STUDY_DIRECTOR
UZ Gent
Abosi Appeadu Kessewa
Role: STUDY_CHAIR
UZ Gent
Decalf Veerle
Role: STUDY_CHAIR
UZ Gent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BC-08720-ADP
Identifier Type: -
Identifier Source: org_study_id
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