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

Sponsor

Meir Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03056586

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Use of Pessary Reduce the Number of Prolapse Recurrence Uterine Prolapse Cystocele Rectocele	Device: vaginal pessary	N/A

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 Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Mar 20, 2017

Anticipated Primary Completion Date :

Dec 20, 2018

Anticipated Study Completion Date :

Dec 20, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klein zvi, Head of urogynecology unit, Meir Medical Center

ClinicalTrials.gov Identifier:

NCT03056586

Other Study ID Numbers:

0188-16-MMC

First Posted:

Feb 17, 2017

Last Update Posted:

Mar 7, 2017

Last Verified:

Mar 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2017