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Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

NCT02680145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-08-20

Study results available
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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.

Conditions

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

Interventions

DEVICE

Preoperative Pessary Use

Pessary use for 1-4 weeks prior to surgical prolapse repair

Sponsors & Collaborators

Principal Investigators

  • John A Occhino, MD, MS · Mayo Clinic

  • Brian Linder, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-11
Primary Completion
2019-10-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02680145 on ClinicalTrials.gov