Phase 2
N=54
Topical Anesthetic Use In Pessary Management
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02380742 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain — 1.76; 3.81 Centimeters — p=.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lidocaine-prilocaine cream (Drug); Placebo cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Loyola University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain |
1.76; 3.81 | .02 sig |
| SECONDARY VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training |
1.81; 3.76 | .03 sig |
| SECONDARY VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age |
1.88; 3.69 | .03 sig |
| SECONDARY VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain |
0.61; 1.68 | .09 |
Summary
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.
Eligibility Criteria
Inclusion Criteria
- Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
- Read and speak the English language
Exclusion Criteria
- Non-English speaking
- Allergy or contraindication to topical anesthetic
- Participation/randomization in the study at a previous visit
- Currently pregnant or lactating or planning a pregnancy within the next 6 months
Data sourced from ClinicalTrials.gov (NCT02380742). 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.