The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse
- Conditions
- CystoceleRectoceleUse of Pessary Reduce the Number of Prolapse RecurrenceUterine Prolapse
- Registration Number
- NCT03056586
- Lead Sponsor
- Meir Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- all healthy patients with genital prolapse grade 3-4, going for vaginal surgery
- age 30-80years
- patients with pelvic inflammatory disease
- patients after pelvic irradiation
- large vaginal erosion
- vaginal bleeding uncontrolled or undiagnosed
- patients going for surgery with mesh
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair. 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
- Secondary Outcome Measures
Name Time Method