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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 : Not yet recruiting
First Posted : February 17, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Klein zvi, 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.


Condition or disease Intervention/treatment Phase
Use of Pessary Reduce the Number of Prolapse Recurrence Uterine Prolapse Cystocele Rectocele Device: vaginal pessary Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   No
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

Responsible Party: Klein zvi, Head of urogynecology unit, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03056586     History of Changes
Other Study ID Numbers: 0188-16-MMC
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Cystocele
Recurrence
Prolapse
Uterine Prolapse
Rectocele
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Uterine Diseases
Genital Diseases, Female
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia