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Local Anesthesia Before Bulkamid Injection

Local Anesthesia Before Bulkamid Injection

Non Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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 details
    Stress Urinary Incontinence
    Intrinsic Sphincter Deficiency

NCT06043063

Medstar Health Research Institute

20 August 2025

FAQs

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