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Procedure

Local Anesthesia Before Bulkamid Injection for Stress Urinary Incontinence (LAB Trial)

N/A

Recruiting

Research Sponsored by Medstar Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia

Be older than 18 years old

Must not have

Bladder or urothelial malignancy

Prior radiation to pelvic floor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)

Awards & highlights

No Placebo-Only Group

Summary

This trial compares pain levels after PAHG injection with two types of anesthesia to see which is better.

Who is the study for?

This trial is for women over 18 with stress urinary incontinence or intrinsic sphincter deficiency, who speak English and are scheduled for a PAHG injection without sedation. It's not for pregnant women, those with neurogenic bladder issues, catheter needs, pelvic floor radiation history, or allergies to PAHG.

What is being tested?

The study is testing the effectiveness of different anesthesia methods before Bulkamid injections: periurethral block versus EMLA cream versus topical lidocaine. The goal is to see which method best reduces pain after the procedure.

What are the potential side effects?

Possible side effects from the anesthetics may include temporary numbness around the application area, mild skin reactions like redness or itching at the cream site, and rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My procedure is scheduled without the need for being put to sleep or spinal anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have bladder or urothelial cancer.

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I have had radiation treatment to my pelvic area.

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I have a condition where my bladder doesn't empty properly due to a nerve problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at two-week and twelve-week follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at two-week and twelve-week follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at two-week and twelve-week follow-up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual analog scale (VAS) for pain

Secondary study objectives

Duration of procedure

Incomplete bladder emptying

International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Topical anesthesia aloneExperimental Treatment2 Interventions

2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min

Group II: Topical anesthesia with periurethral blockActive Control3 Interventions

2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min + periurethral block (5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock to depth of 1.5 cm using 25G needle) Block sits for 5 min if lidocaine, 10 min if bupivacaine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EMLA cream

2013

Completed Phase 4

~180

0 / 4Eligibility criteria met