6 Clinical Trials for Various Conditions
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).
Primary Aim 1. To measure difference in pain via Faces, Legs, Activity, Cry and Consolability (FLACC) Pain Scale score at the time of transurethral bladder catheterization for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization. Secondary Aims 1. To assess gender differences in pain control during transurethral bladder catheterization with and without pain control using intraurethral 2% lidocaine jelly. 2. To assess patient discomfort with administration of intraurethral 2% lidocaine jelly. To assess parental impression of discomfort between intervention and control groups. 3. To assess pain associated with the administration of intraurethral 2% lidocaine jelly. 4. To measure difference in pain via Modified Behavioral Pain Scale (MBPS) score at the time of TUBC for urine collection in children who do and do not receive intraurethral 2% lidocaine jelly prior to catheterization.
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.
This study is designed to determine primarily if there is a difference in perceived pain in patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus local lidocaine plus nitrous oxide gas. Patients will be randomized to a control group (local lidocaine plus room air) or a intervention group (local lidocaine plus 50% nitrous oxide/50% oxygen inhaled mixture). Their pain will be assessed immediately after the procedure, and their recollection of pain will also be assessed at their 2 week post-procedure visit. There are other secondary outcome measures as well; please see outcome measures section for full description.
The purpose of this study is to determine if a single application of Lidocaine gel topical anesthesia is as effective in decreasing the discomfort associated with urinary catheterization as two applications, within our pediatric population. Currently, two applications is our standard of care within our pediatric Radiology Department. Urinary catheterization is the process of placing a flexible tube into the urinary opening (urethra), to drain urine or instill radiographic solution for study of the anatomy and/or function of the urinary system. Members of the study team hypothesize equivalence in the observer reported catheterization pain scores as measured by the FLACC pain scale. The study is designed to obtain conclusive data to guide clinical practice. The study team hypothesizes that statistically similar levels of analgesia will be observed with the single application procedure as compared to the multiple application technique.
In Emergency Departments (ED) across the nation there is renewed interest in finding ways to alleviate the pain and discomfort associated with many of the procedures that children must undergo. In a policy by the American Academy of Pediatrics, a nationally recognized advocate for children, physicians are urged to advocate for child-specific research in pain management and the effective use of pain medication to ensure compassionate and competent management of pain. (AAP Statement, 2001) Pediatric urethral catheterizations are one such procedure in which children experience significant pain.(11) In present care, children over 2 months of age do not routinely receive intervention for urethral catheterization related anxiety and pain, and, anecdotal reports suggest that most require physical restraint to complete the procedure. Lidocaine is an anesthetic agent that provides relief from pain during many commonly performed ED procedures. Intraurethral Lidocaine has been shown to decrease pain associated with urethral catheter placement in cystograms, however, Lidocaine is not routinely used for urethral catheterizations in the CHOA ED. This study aims to investigate the potential use of Lidocaine as an anesthetic agent during urethral catheterization of children. Recently, two specific studies were performed investigating the use of Lidocaine to decrease discomfort associated with urethral catheterization. Using the strengths of both previously published studies, our study will use Lidocaine both topically and instilled into the urethra. Investigators plan to perform a prospective three-arm double-blinded randomized clinical trial investigating the effectiveness of Lidocaine jelly as a analgesic when used as a lubricant for urinary catheterization. Investigators aim to demonstrate that Lidocaine used as a lubricant anesthetic for urethral catheterization will provide a safe, time-efficient, and relatively easy way to decrease pediatric pain in the emergency department setting.