The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse (pfgp)
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|ClinicalTrials.gov Identifier: NCT03056586|
Recruitment Status : Unknown
Verified March 2017 by Klein zvi, Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 17, 2017
Last Update Posted : March 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Use of Pessary Reduce the Number of Prolapse Recurrence Uterine Prolapse Cystocele Rectocele||Device: vaginal pessary||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative|
|Estimated Study Start Date :||March 20, 2017|
|Estimated Primary Completion Date :||December 20, 2018|
|Estimated Study Completion Date :||December 20, 2019|
Experimental: 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.
Device: 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.
No Intervention: 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.
- Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair. [ Time Frame: 24 month ]The investigators hope to see a low percentage of prolapse recurrence in the study (pessary) group, comparing to the control (no pessary) group