Lidocaine for Pain After Urodynamic Testing

Status Completed

Clinical Trial Summary

Clinical Trial Description

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). Additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing.

Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it contains no active drug. The assigned study regimen will be chosen by chance, like flipping a coin. Participants will have an equal (50/50) chance of being given either study regimen. Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. Additionally, a member of the study team will ask participants about their pain level before and after the testing. The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03390790
Study type	Interventional
Source	Atlantic Health System
Contact
Status	Completed
Phase	Phase 4
Start date	January 25, 2018
Completion date	March 29, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05534412` - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence	N/A
Recruiting	`NCT05515198` - Improving Care for Women With Urinary Incontinence (EMPOWER)	N/A
Completed	`NCT04071301` - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence	N/A
Completed	`NCT03623880` - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders	N/A
Recruiting	`NCT05880862` - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls	Early Phase 1
Recruiting	`NCT04159467` - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet	N/A
Completed	`NCT05485922` - Performance of a Single-use Intermittent Micro-hole Zone Catheter	N/A
Completed	`NCT06268782` - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women	N/A
Not yet recruiting	`NCT03027986` - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy	N/A
Recruiting	`NCT02490917` - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence	N/A
Enrolling by invitation	`NCT02530372` - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women	N/A
Enrolling by invitation	`NCT02529371` - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients	N/A
Completed	`NCT02549729` - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy	N/A
Completed	`NCT02600676` - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis	N/A
Completed	`NCT02338726` - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study	N/A
Completed	`NCT02368262` - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy	N/A
Completed	`NCT02239796` - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence	N/A
Completed	`NCT01942681` - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride	N/A
Recruiting	`NCT01804153` - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)	Phase 1/Phase 2
Completed	`NCT01520948` - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.