Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Pelvic Organ Prolapse Clinical Trial

Official title:

Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680145
• Other study ID #: 15-006186
• Status: Completed
• Phase: N/A
• Start date: March 11, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Pelvic Floor Prolapse
• Pelvic Organ Prolapse
• Prolapse
• Uterine Prolapse
• Vaginal Vault Prolapse

Intervention

Device:
• Preoperative Pessary Use
Pessary use for 1-4 weeks prior to surgical prolapse repair

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials