Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/10/2019 |
| Start Date: | March 11, 2016 |
| End Date: | December 31, 2019 |
| Contact: | Heather R LaBrec |
| Email: | labrec.heather@mayo.edu |
| Phone: | 507-293-3446 |
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.
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.
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.
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.
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
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