Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
Completed · Not applicable
Conditions studied: Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
In brief
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.
Key facts
- Study ID
- NCT02680145
- Run by
- Mayo Clinic
- People needed
- 58
- Starts
- 2016-03-11
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2020-08-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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