Clinical trial NCT02680145: Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
Official title: Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Vault Prolapse
Pelvic Organ Prolapse
Uterine Prolapse
Pelvic Floor Prolapse
Keywords: Pessary
Prolapse
Cystocele
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Global Impression of Improvement (PGI-I) Score
timeFrame: 3 months postoperatively
measure: Prolapse Symptom Severity
timeFrame: Baseline, 3 month post surgery
measure: Bother of Bladder/Vaginal/Bowel Symptoms
timeFrame: Baseline, 3 month post surgery
measure: Overactive Bladder Symptom Score (OABSS)
timeFrame: Baseline, 3 month post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John A Occhino, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Brian Linder, MD
role: STUDY_CHAIR
References: