N/A Completed N=90 Randomized Quadruple-blind Treatment

Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics

Source: ClinicalTrials.gov NCT01612156 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcomePrimary: Pain During the Pelvic Floor Examination — 0.4; 0.9; 1.3; 3.6 units on Wong Baker pain scale

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.