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NCT03056586 Clinical Trial

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

Cystocele Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03056586
Other study ID # 0188-16-MMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 15, 2017
Last updated March 6, 2017
Start date March 20, 2017
Est. completion date December 20, 2019

Study information
Verified date March 2017
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 20, 2019
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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 24 month
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