Lidocaine 2% Jelly for Pelvic Floor Disorders (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

Pelvic Floor Disorders
Urinary Incontinence
Vaginal Prolapse
Urodynamic Incontinence
Pelvic Organ Prolapse
Pelvic organ prolapse
Uterine 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes. for reporting.

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).

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