Phase 4
N=137
Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00883103 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain — 1; 2 Scores on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 2% Lidocaine jelly (Drug); Plain aqueous gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Baystate Medical Center
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain |
1; 2 | <0.001 sig |
Summary
The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.
Eligibility Criteria
Inclusion Criteria
- All women who presented to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse
Exclusion Criteria
- Being a minor
- Pregnancy
- Allergy to Lidocaine or aqueous lubricant gel
- Any current use of analgesia
- Structural abnormalities of the urethra
- Active genital Herpes or other vulvovaginal infections or inability to cooperate with pain assessment due to mental disorders.
Data sourced from ClinicalTrials.gov (NCT00883103). 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.