An interventional study of vaginal pessary in Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse and Cystocele, sponsored by Meir Medical Center. Status unknown. Open to female participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Prevention
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.
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.
111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 76 interventional studies indexed under Uterine Prolapse.
Browse Uterine Prolapse studies →Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
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
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.
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.
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
Time frame: 24 month
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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