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Phase 4 Completed N=137 Randomized Quadruple-blind Prevention

Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test

Source: ClinicalTrials.gov NCT00883103 ↗
Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: 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

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.

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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