NCT03056586

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-20
• Primary completion: 2018-12-20
• Completion: 2019-12-20
• First posted: 2017-02-17
• Last updated: 2017-03-07

Regulatory

• FDA-regulated device study