CompletedPhase 4

Lessons on Urethral Lidocaine in Urodynamics

United States63 participantsStarted 2019-08-14

Plain-language summary

This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.

Who can participate

Age range18 Years

SexFEMALE

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

Inclusion Criteria: * Female patients * \>18 years of age * Already scheduled (or being scheduled) for UDS to assess urinary incontinence * Able to speak and read in English Exclusion Criteria: * Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome * Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease, multiple sclerosis, myasthenia gravis, recent stroke) * Active UTI * Pelvic organ prolapse that is unable to be easily reduced * Pregnancy or breastfeeding * Allergy or hypersensitivity to lidocaine or local anesthetics

What they're measuring

Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.

Timeframe: Within same visit, approximately 90-120 minutes.

Trial details

NCT IDNCT04038099

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-18

Results submitted2023-03-01

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