Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Mayo Clinic

Status

Completed

Conditions

Uterine Prolapse

Pelvic Floor Prolapse

Pelvic Organ Prolapse

Vaginal Vault Prolapse

Treatments

Device: Preoperative Pessary Use

Study type

Interventional

Funder types

Other

Identifiers

NCT02680145

15-006186

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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