Your session is about to expire
← Back to Search
Local Anesthetic
Lessons on Urethral Lidocaine in Urodynamics (LULU Trial)
Phase 4
Waitlist Available
Led By Christina M Hegan, APRN WHNP-BC
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will test if a numbing jelly can reduce pain and affect bladder function measurements in patients undergoing bladder testing.
Eligible Conditions
- Urinary Incontinence
- Lower Urinary Tract Symptoms
- Uterine Prolapse
- Pelvic Floor Disorders
- Pelvic Organ Prolapse
- Pelvic organ prolapse
- Urethral Issue
- Pelvic Floor Dysfunction
- Cystocele
- Vaginal Vault Prolapse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Secondary study objectives
Filling Metrics: Number of Participants With Detrusor Overactivity
Filling Metrics: Number of Participants With Normal Bladder Compliance
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).
+7 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Lidocaine 2% JellyActive Control1 Intervention
5ml of Lidocaine 2% Jelly
Group II: Water Based Lubricating JellyPlacebo Group1 Intervention
5ml of Water Based Lubricating Jelly
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,620 Total Patients Enrolled
4 Trials studying Urinary Incontinence
1,354 Patients Enrolled for Urinary Incontinence
Christina M Hegan, APRN WHNP-BCPrincipal InvestigatorUniversity of Texas Southwestern Medical Center