The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse

Study Overview
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Brief Summary
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Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation. 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.

Detailed Description
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All patients going for vaginal surgery for genital prolapse, stage 3-4, with cystocele, rectocele or uterine cervix prominent from the vagina. These patients, after signing an informed consent, a vaginal pessary will insert at the end of the operation and will stay for 4 weeks post-op. After 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.

Official Title
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The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative

Conditions
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Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse, Cystocele, Rectocele

Intervention / Treatment
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* Device: vaginal pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all healthy patients with genital prolapse grade 3-4, going for vaginal surgery age 30-80years Exclusion Criteria: patients with pelvic inflammatory disease patients after pelvic irradiation large vaginal erosion vaginal bleeding uncontrolled or undiagnosed patients going for surgery with mesh

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. study group<br>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. | Device: vaginal pessary<br>* 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.<br>|
| No Intervention: 2. control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair. | The investigators hope to see a low percentage of prolapse recurrence in the study (pessary) group, comparing to the control (no pessary) group | 24 month |