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

Clalit Health Services

Status: Unknown

Conditions: Uterine Prolapse; Cystocele; Use of Pessary Reduce the Number of Prolapse Recurrence; Rectocele

Treatments: Device: vaginal pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT03056586

0188-16-MMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

1. study group

Experimental group

Description:

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.

Treatment:

Device: vaginal pessary

2. control

No Intervention group

Description:

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.