Local Anesthesia Before Bulkamid Injection (LAB)

MedStar Health

Status: Terminated

Conditions: Intrinsic Sphincter Deficiency; Stress Urinary Incontinence

Treatments: Procedure: Periurethral block; Procedure: EMLA cream; Procedure: Topical lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06043063

STUDY00006172

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG
• English-speaking
• Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia

Exclusion criteria

• Pregnancy
• Neurogenic bladder
• Pre-existing need for intermittent catheterization or indwelling catheter
• Bladder or urothelial malignancy
• Prior radiation to pelvic floor
• Known allergy/sensitivity to PAHG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Topical anesthesia alone

Experimental group

Description:

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

Treatment:

Procedure: Topical lidocaine

Procedure: EMLA cream

Topical anesthesia with periurethral block

Active Comparator group

Description:

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:

Procedure: Topical lidocaine

Procedure: EMLA cream

Procedure: Periurethral block