N/A
N=90
Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
Pelvic Floor Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01612156 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Pain During the Pelvic Floor Examination — 0.4; 0.9; 1.3; 3.6 units on Wong Baker pain scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 2% lidocaine gel (Drug); Water based lubricant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Southern California
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain During the Pelvic Floor Examination |
0.4; 0.9; 1.3; 3.6; 1.4; 3.9 | — |
| SECONDARY Embarrassment With Pelvic Floor Examination |
2; 2 | — |
Summary
The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when compared to lubricant gel.
Eligibility Criteria
Inclusion Criteria
- Women 18 years of age or older
- Scheduled to undergo multichannel urodynamic study
- Able to give informed consent
- Able to read and write in English or Spanish
Exclusion Criteria
- Any contraindication to multichannel urodynamic study
- Allergy to water based lubricant or lidocaine
- Any active pelvic or lower urinary tract infection
Data sourced from ClinicalTrials.gov (NCT01612156). 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.