The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse
NCT ID: NCT03056586
Last Updated: 2017-03-07
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
NA
100 participants
INTERVENTIONAL
2017-03-20
2019-12-20
Brief Summary
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In this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.
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Detailed Description
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After 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1. study group
100 patients who agree to participate in the study, will be operate according to our protocol for pelvic organ prolapse. At the end of the operation a vaginal pessary will be inserted and suture to the vaginal walls for a 4 week period.
Follow-up will be after 3, 6, and 12 month period.
vaginal pessary
A vaginal pessary will be inserted at the end of the operation, for genital prolapse, and will be sutured to the vaginal wall. The pessary will stay in the vagina for 4 weeks.
2. control
100 Women who will refuse to participate in the study, will agree to be follow-up by our team for 3, 6, and 12 month post operative.
No interventions assigned to this group
Interventions
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vaginal pessary
A vaginal pessary will be inserted at the end of the operation, for genital prolapse, and will be sutured to the vaginal wall. The pessary will stay in the vagina for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* age 30-80years
Exclusion Criteria
* patients after pelvic irradiation
* large vaginal erosion
* vaginal bleeding uncontrolled or undiagnosed
* patients going for surgery with mesh
30 Years
80 Years
FEMALE
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Klein zvi
Head of urogynecology unit
Other Identifiers
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0188-16-MMC
Identifier Type: -
Identifier Source: org_study_id
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