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

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medstar Health Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.

Eligibility Criteria

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.

Inclusion Criteria

I am a woman over 18 with stress urinary incontinence interested in PAHG.

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

English-speaking

Exclusion Criteria

Pregnancy

You need to use a catheter to empty your bladder.

I have bladder or urothelial cancer.

+3 more

Participant Groups

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.

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