Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Uterine Prolapse; Vaginal Vault Prolapse; Pelvic Floor Prolapse
• Intervention / Treatment: Device: Preoperative Pessary Use

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative Pessary Use; All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse	Device: Preoperative Pessary Use; Pessary use for 1-4 weeks prior to surgical prolapse repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Improvement (PGI-I) Score	Number of participants considered treatment success assessed using the 7-point Likert scale of the Patient Global Impression of Improvement (PGI-I) of 1= very much better and 7=very much worse. Patient's will be considered treatment success if they answer "much better" or "very much better" on the PGI-I scale.	3 months postoperatively
Prolapse Symptom Severity	Mean value of score on self-reported Pelvic Organ Prolapse Distress Inentory-6 (POPDI-6) questionnaire. Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.	Baseline, 3 month post surgery
Bother of Bladder/Vaginal/Bowel Symptoms	Mean value of score on self-reported Floor Impact Questionnaire-7 (PFIQ-7). Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.	Baseline, 3 month post surgery
Overactive Bladder Symptom Score (OABSS)	Mean value of score on self-reported Overactive Bladder Symptom Score (OABSS) questionnaire. Minimum scale score = 0; maximum scale score = 15 and a higher score indicates worse outcome.	Baseline, 3 month post surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John A Occhino, MD, MS, Mayo Clinic; Study Chair: Brian Linder, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2016
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cystocele; Pessary; Prolapse
• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Uterine Prolapse
• Other Study ID Numbers: 15-006186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes