N/A
Completed N=58
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
Vaginal Vault Prolapse · pelvic organ prolapse · uterine prolapse · Pelvic Floor Prolapse
Source: ClinicalTrials.gov NCT02680145 ↗
Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Patient Global Impression of Improvement (PGI-I) Score — 39 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Global Impression of Improvement (PGI-I) Score |
39 | — |
| PRIMARY Prolapse Symptom Severity |
48.6; 7.3 | 0.001 sig |
| PRIMARY Bother of Bladder/Vaginal/Bowel Symptoms |
72.1; 18.8 | 0.001 sig |
| PRIMARY Overactive Bladder Symptom Score (OABSS) |
12.0; 9.6 | 0.005 sig |
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
Data sourced from ClinicalTrials.gov (NCT02680145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.