Local Anesthesia Before Bulkamid Injection

Study Overview
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Brief Summary
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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.

Official Title
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Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial

Conditions
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Intrinsic Sphincter Deficiency, Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Topical lidocaine
* Procedure: EMLA cream
* Procedure: Periurethral block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical anesthesia alone<br>2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min | Procedure: Topical lidocaine<br>* Topical anesthetic<br>* Other names: Intraurethral 2% lidocaine gel;Procedure: EMLA cream<br>* Topical anesthetic<br>* Other names: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream;|
| Active Comparator: Topical anesthesia with periurethral block<br>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 | Procedure: Topical lidocaine<br>* Topical anesthetic<br>* Other names: Intraurethral 2% lidocaine gel;Procedure: EMLA cream<br>* Topical anesthetic<br>* Other names: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream;Procedure: Periurethral block<br>* 5 cc 1% lidocaine or 0.25% bupivacaine at 3 and 9 o'clock (periurethral tissues) to depth of 1.5 cm using 25G needle<br>* Other names: 1% lidocaine or 0.25% bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) for pain | Visual analog scale for pain uses a scale from 0-10 corresponding to reported pain levels with 0 indicating no pain and 10 indicating most severe pain possible | Ascertained at end of procedure (withdrawal of cystoscope) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of procedure | in seconds | Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope) | 
| Incomplete bladder emptying | Inability to void after procedure | Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope) | 
| Need for re-injection of PAHG | Requirement for top-off or repeat injection due to persistent symptoms | Assessed at follow-up 2 weeks post-procedure | 
| International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI) | 3 items on frequency/quantity of leakage and impact on quality on life (range 0-21 with lower score indicating lower severity of incontinence symptoms and higher score indicating higher severity of incontinence symptoms) | Assessed at baseline and at two-week and twelve-week follow-up visit | 
| Patient Global Impression of Improvement scale (PGI-I) | 1 item on relative change in symptoms following treatment (range 1-7 with lower score indicating greater improvement in incontinence symptoms following intervention and higher score indicating lower improvement in incontinence following intervention) | Assessed at two-week and twelve-week follow-up visit |