Contribution of Urethral Sensory Feedback in Voiding Efficiency
Completed · Not applicable · Has a placebo group
Conditions studied: Urethral Anesthesia
In brief
The purpose of this study is to evaluate how urethral anesthesia 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).
Key facts
- Study ID
- NCT03637582
- Run by
- Duke University
- People needed
- 18
- Starts
- 2018-11-26
- Expected to finish
- 2018-12-21
- Last updated by the study team
- 2019-11-14
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
- Alcoholism or failed CAGE questionnaire
- Abnormal baseline uroflow
- Reported pain on baseline VAS (score >10)
Where it is running
- Duke University Campus — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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