The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse (pfgp)

March 6, 2017 updated by: Klein zvi, Meir Medical Center

The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2017

Primary Completion (Anticipated)

December 20, 2018

Study Completion (Anticipated)

December 20, 2019

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0188-16-MMC

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystocele

Clinical Trials on vaginal pessary

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe