Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Conditions
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Uterine Prolapse, Vaginal Vault Prolapse, Pelvic Organ Prolapse, Pelvic Floor Prolapse

Intervention / Treatment
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* Device: Preoperative Pessary Use


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pessary, Prolapse, Cystocele