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Local Anesthetic

Lidocaine 2% Jelly for Vaginal Prolapse (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

LULU Trial Summary

This trial will assess whether use of intraurethral 2% lidocaine jelly impacts sensation during filling and determine if it impacts pain/discomfort, filling metrics, and voiding metrics.

Eligible Conditions
  • Vaginal Prolapse
  • Uterine Prolapse
  • Urinary Incontinence
  • Urethral Issue
  • Pelvic Floor Dysfunction
  • Cystocele
  • Vaginal Vault Prolapse
  • Pelvic Organ Prolapse

LULU Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more

LULU 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

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,736 Total Patients Enrolled
1 Trials studying Vaginal Prolapse
206 Patients Enrolled for Vaginal Prolapse
Christina M Hegan, APRN WHNP-BCPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Lessons on Urethral Lidocaine in Urodynamics
Christina Hegan 2019. "Lessons on Urethral Lidocaine in Urodynamics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038099.
~11 spots leftby Apr 2025
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