Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Preoperative Pessary Use	Preoperative Pessary Use	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse

Primary Outcome Measures

Name	Time	Method
Prolapse Symptom Severity	Baseline, 3 month post surgery	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.
Patient Global Impression of Improvement (PGI-I) Score	3 months postoperatively	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.
Bother of Bladder/Vaginal/Bowel Symptoms	Baseline, 3 month post surgery	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.
Overactive Bladder Symptom Score (OABSS)	Baseline, 3 month post surgery	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.