CompletedNot Applicable

Contribution of Urethral Sensory Feedback in Voiding Efficiency

United States18 participantsStarted 2018-11-26

Plain-language summary

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).

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Voiding Efficiency

Timeframe: duration of urodynamic study, 2 hours

Trial details

NCT IDNCT03637582

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-21

View on ClinicalTrials.gov More Urethral Anesthesia trials