Back to resultsThe Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse (pfgp)
Primary Purpose
Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse, Cystocele
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vaginal pessary
Sponsored by
About this trial
This is an interventional prevention trial for Use of Pessary Reduce the Number of Prolapse Recurrence
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1. study group
2. control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03056586
Brief Title
The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse
Acronym
pfgp
Official Title
The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Anticipated)
Primary Completion Date
December 20, 2018 (Anticipated)
Study Completion Date
December 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse, Cystocele, Rectocele
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1. study group
Arm Type
Experimental
Arm Description
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.
Arm Title
2. control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
vaginal pessary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair.
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse
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