Urinary Incontinence Clinical Trial
Official title:
The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women
Verified date | July 2019 |
Source | Atlantic Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
Status | Completed |
Enrollment | 134 |
Est. completion date | March 29, 2019 |
Est. primary completion date | March 29, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: • All female patients between the ages of 40-80 undergoing urodynamic testing. Exclusion Criteria: - Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks - History of urinary retention - Known or suggested history of urethral syndrome or painful bladder syndrome - Prior anti-incontinence surgery - Prior pelvic surgery with placement of transvaginal mesh - Known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra - History of genital herpes outbreak within the past 3 months - Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations - Neurologic disease affecting urethral sensation - Chronic pelvic pain - Contraindication or allergy to topical anesthetic - Pregnancy - Syncopal episode during preparation for or execution of uroflowometry |
Country | Name | City | State |
---|---|---|---|
United States | Atlantic Health System | Morristown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Atlantic Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing | Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable). | Baseline and 4-6 hours post procedure. | |
Secondary | Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing. | Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable). | Baseline and 24 hours post procedure. | |
Secondary | Patient visual analog pain score (vaginal area only) before procedure, at conclusion of all procedure-related activities, 4-6 hours after procedure, and 24 hours after procedure. | Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable). | Baseline and 24 hours post procedure. | |
Secondary | To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing. | Participants will receive a phone call at 4-6 hours and 24 hours after urodynamic testing. Any study participant-initiated complaints of voiding difficulties within two weeks of the procedure will be documented and addressed. | Baseline and 2 weeks post-procedure. | |
Secondary | Urodynamic findings | Standard urodynamics findings will be analyzed. | At time of procedure. | |
Secondary | Procedure time | Procedure time will be recorded for all subjects. | At time of procedure. |
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 |
NCT02529371 -
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
|
N/A | |
Enrolling by invitation |
NCT02530372 -
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
|
N/A | |
Completed |
NCT02338726 -
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
|
N/A | |
Completed |
NCT02600676 -
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
|
N/A | |
Completed |
NCT02549729 -
Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy
|
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 |