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

NCT03056586 | Unknown FDA Device

• 1 other identifier: 0188-16-MMC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1. study group

EXPERIMENTAL

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.

Device: vaginal pessary

2. control

NO INTERVENTION

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.

Interventions

vaginal pessary DEVICE

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.

1. study group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with pelvic inflammatory disease
• patients after pelvic irradiation
• large vaginal erosion
• vaginal bleeding uncontrolled or undiagnosed
• patients going for surgery with mesh

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Uterine Prolapse; Cystocele; Rectocele

Interventions

Pessaries

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of urogynecology unit

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 17, 2017
• Study Start: March 20, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2019
• Last Updated: March 7, 2017

Record last verified: 2017-03