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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03056586

Acronym

pfgp

Enrollment

100

Registered

2017-02-17

Start date

2017-03-20

Completion date

2019-12-20

Last updated

2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele, Rectocele, Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse

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.

Interventions

DEVICEvaginal 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026