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

Not Applicable

• Conditions: Cystocele; Rectocele; Use of Pessary Reduce the Number of Prolapse Recurrence; Uterine Prolapse
• Interventions: Device: vaginal pessary

• 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-17
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07
• Study Start: 2017-03-20
• Primary Completion: 2018-12-20
• Study Completion: 2019-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• all healthy patients with genital prolapse grade 3-4, going for vaginal surgery
• age 30-80years

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. study group	vaginal pessary	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.

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