Lessons on Urethral Lidocaine in Urodynamics
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- STATUS
- Recruiting
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- End date
- Oct 22, 2022
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- participants needed
- 70
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- sponsor
- University of Texas Southwestern Medical Center
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.
Description
This trial is a randomized, double blind, controlled trial for patients undergoing complex cystometric evaluation. Patients will undergo routine complex cystometric evaluation for acquisition of baseline data using a small amount of intraurethral aqueous jelly for catheter lubrication. Then, they will be randomized to instillation of either placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly. Participants then undergo complex cystometry a second time. Normal variations in studies with placebo will be compared to variations within the 2% lidocaine jelly group to determine if cystometric parameters are altered in any clinically important ways. Patient discomfort will also be evaluated by both the patient and the urodynamics advanced practice nurse.
Details
| Condition | Cystocele, Pelvic Floor Disorders, Genital Prolapse, Disorder of uterus NOS, bladder disorder, Ptosis, pelvic organ prolapse, Genitourinary Prolapse, Uterine Disorders, female cystocele, dropped bladder, Uterine Prolapse, cystocoele, vaginal prolapse, Urethra Issue, Pregnancy Complications, Vaginal Vault Prolapse, Bladder Disorders, Urinary Incontinence |
|---|---|
| Treatment | lidocaine topical, Water-Based Vaginal Lubricant |
| Clinical Study Identifier | NCT04038099 |
| Sponsor | University of Texas Southwestern Medical Center |
| Last Modified on | 7 December 2021 |
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