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Experimental for Pelvic Organ Prolapse
Phase 3
Waitlist Available
Led By Araba A Jackson, MD
Research Sponsored by University of South Florida
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 0 and 10 minutes
Awards & highlights
Study Summary
This trial is testing whether using lidocaine jelly can reduce pain during pessary removal in patients with vaginal prolapse.
Eligible Conditions
- Pelvic Organ Prolapse
- Stress Incontinence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 and 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and 10 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Pain
Genital Hiatus with Valsalva
Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.
Group II: ControlPlacebo Group1 Intervention
Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine Hcl 2% Jelly
2022
Completed Phase 3
~70
Find a Location
Who is running the clinical trial?
University of South FloridaLead Sponsor
407 Previous Clinical Trials
186,743 Total Patients Enrolled
4 Trials studying Pelvic Organ Prolapse
347 Patients Enrolled for Pelvic Organ Prolapse
Araba A Jackson, MDPrincipal InvestigatorUniversity of South Florida
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with participating in this trial?
"Given that this is a Phase 3 trial - signifying that there is some data supporting efficacy as well as multiple rounds of supportive safety data - our team has given Experimental a score of 3 in terms of safety."
Answered by AI
Are there any limitations on how many patients can be a part of this clinical trial?
"Indeed, the clinicaltrials.gov website verifies that this trial is still recruiting patients. The listing was first published on September 8th, 2022 and updated 5 days ago. They are looking for 96 subjects from a single location."
Answered by AI
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