Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

NCT ID: NCT02680145

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-11
• Study Completion Date: 2019-12-31

Brief Summary

This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally, we will assess the impact that preoperative pessary use has on patient self-reported preparedness for surgery.

Detailed Description

It is anticipated that this trial will define the clinical utility of routine preoperative pessary placement, and by shaping patient expectations and increasing preparedness for surgery, we anticipate improving satisfaction and quality of life.

At the initial office visit baseline symptoms are evaluation with validated questionnaire.

The patients' will undergo pessary fitting at least 7 days (but no more than 28 days) prior to scheduled surgical prolapse repair.

Symptomatic change from baseline will be assessed with validated questionnaire preoperatively.

The pessary will be removed at the time of surgery, and the patient will undergo surgical correction of their pelvic organ prolapse (including all restorative surgical procedures, abdominal and transvaginal). A concomitant anti-incontinence procedure will be performed at the discretion of the treating physician in consultation with the patient.

The patients' symptomatic outcome from surgery will then be reassessed by validated questionnaire at 6 weeks and 3 months postoperatively.

Conditions

Vaginal Vault Prolapse; Pelvic Organ Prolapse; Uterine Prolapse; Pelvic Floor Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative Pessary Use

All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse

Group Type: EXPERIMENTAL

Preoperative Pessary Use

Intervention Type: DEVICE

Pessary use for 1-4 weeks prior to surgical prolapse repair

Interventions

Preoperative Pessary Use

Pessary use for 1-4 weeks prior to surgical prolapse repair

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Older than 18 years of age
• With symptomatic pelvic organ prolapse
• Electing for surgical repair of pelvic organ prolapse (transvaginal or transabdominal) at least 7 days after office consultation
• Understand and have signed written informed consent for preoperative pessary placement.

Exclusion Criteria

• Previous use of a pessary for pelvic organ prolapse
• Patients undergoing obliterative prolapse surgery (i.e. Colpocleisis),
• Are scheduled for surgery for pelvic organ prolapse less than 7 days after office consultation or greater than 4 weeks after office consultation
• Have an isolated rectocele
• Have allergies to both latex and silicone
• Have an active pelvic infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

John A. Occhino

Assistant Professor of Obstetrics-Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John A Occhino, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Brian Linder, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

15-006186

Identifier Type: -

Identifier Source: org_study_id