N/A N=23 Randomized Double-blind Basic Science

Effect of Urethral Analgesia on Voiding

Urethral Analgesia

Bottom Line

View on ClinicalTrials.gov: NCT02823431 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Voiding Efficiency — 87; 90 Percent voiding efficiency

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: lidocaine gel (Drug); Plain aqueous gel (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Duke University
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Voiding Efficiency	87; 90	—
SECONDARY Detrusor Pressure at Maximum Flow	37.6; 31	—
SECONDARY Number of Participants With Interrupted Urinary Flow Pattern During Micturition	4; 0	—
SECONDARY Visual Analog Scale Scores (Measure of Discomfort) After Catheterization	26; 19	—

Summary

The purpose of this study is to evaluate how urethral analgesia impacts voiding efficiency in healthy women. The investigator hypothesizes that anesthetizing the urethral with lidocaine gel will decrease voiding efficiency as measured by standard bladder testing (urodynamic testing).

Eligibility Criteria

Inclusion Criteria

Females ages 18-60 years
No health conditions as indicated in exclusion criteria
Able to provide informed consent and agree to the risks of the study
Willing to abstain from caffeine and alcohol for 24 hours
Willing to avoid taking anticholinergic medications (for reasons other than incontinence; e.g., diphenhydramine) for one week prior to the procedure

Exclusion Criteria

Pelvic organ prolapse past the hymen
Multiple sclerosis, myasthenia gravis, Parkinson's Disease, stroke within the past 6 months
Interstitial cystitis / Bladder Pain Syndrome
Recurrent (≥ 3/year) urinary tract infections
Positive pregnancy test at the time of consent
≤ 6 weeks postpartum or if breastfeeding
Positive urine dip (>+1nitrites or >1+LE) and urinary symptoms at the time of consent
>1+ blood on urinary dip
Morbid obesity (BMI >40)
Taking anticholinergic medications for urinary incontinence
>2 replies of ≥ "sometimes" on the Lower Urinary Tract Symptoms questionnaire at the time of consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02823431). 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.