Local Anesthesia Before Bulkamid Injection

Not Applicable

Terminated

• Conditions: Stress Urinary Incontinence; Intrinsic Sphincter Deficiency
• Interventions: Procedure: Topical lidocaine; Procedure: EMLA cream; Procedure: Periurethral block

• Registration Number: NCT06043063
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Primary Completion: 2024-08-16
• Study Completion: 2024-12-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical anesthesia alone	EMLA cream	2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min
Topical anesthesia alone	Topical lidocaine	2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min
Topical anesthesia with periurethral block	EMLA cream	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
Topical anesthesia with periurethral block	Topical lidocaine	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
Topical anesthesia with periurethral block	Periurethral block	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

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) for pain	Ascertained at end of procedure (withdrawal of cystoscope)	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

Secondary Outcome Measures

Name	Time	Method
Duration of procedure	Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)	in seconds
Need for re-injection of PAHG	Assessed at follow-up 2 weeks post-procedure	Requirement for "top-off" or repeat injection due to persistent symptoms
Patient Global Impression of Improvement scale (PGI-I)	Assessed at two-week and twelve-week follow-up visit	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)
Incomplete bladder emptying	Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)	Inability to void after procedure
International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)	Assessed at baseline and at two-week and twelve-week follow-up visit	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)

Trial Locations

Locations (3)

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

MedStar Lafayette Medical Centre; 🇺🇸 Washington, District of Columbia, United States