Local Anesthesia Before Bulkamid Injection (LAB)

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

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Intrinsic Sphincter Deficiency
• Intervention / Treatment: Procedure: Topical lidocaine; Procedure: EMLA cream; Procedure: Periurethral block

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neha G Gaddam, M.D.; Phone Number: 832-865-0244; Email: neha.g.gaddam@medstar.net
• Study Contact Backup: Name: Neha G Gaddam, M.D.; Phone Number: 832-865-0244; Email: gaddam.ng@gmail.com

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
      • Contact: Neha G Gaddam, MD; Phone Number: 832-865-0244; Email: neha.g.gaddam@medstar.net
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
      • Contact: Neha G Gaddam, MD; Phone Number: 832-865-0244; Email: neha.g.gaddam@medstar.net
    • Washington, District of Columbia, United States, 20036
      • Recruiting
      • MedStar Lafayette Medical Centre
      • Contact: Neha G Gaddam, MD; Phone Number: 832-865-0244; Email: neha.g.gaddam@medstar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical anesthesia alone; 2.5% EMLA cream + intraurethral 2% lidocaine gel for 15 min	Procedure: Topical lidocaine; Topical anesthetic; Other Names: Intraurethral 2% lidocaine gel; Procedure: EMLA cream; Topical anesthetic; Other Names: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream
Active Comparator: Topical anesthesia with 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	Procedure: Topical lidocaine; Topical anesthetic; Other Names: Intraurethral 2% lidocaine gel; Procedure: EMLA cream; Topical anesthetic; Other Names: 2.5%/2.5% EMLA (eutectic mixture of local anesthetics) cream; Procedure: Periurethral block; 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; Other Names: 1% lidocaine or 0.25% bupivacaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urinary Incontinence, Stress; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Combined; Anesthetics; Lidocaine; Anesthetics, Local; Lidocaine, Prilocaine Drug Combination; Bupivacaine
• Other Study ID Numbers: STUDY00006172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No