Local Anesthesia Before Bulkamid Injection

Stopped early · Not applicable

Conditions studied: Stress Urinary Incontinence, Intrinsic Sphincter Deficiency

In brief

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.

Key facts

Study ID

NCT06043063

Run by

Medstar Health Research Institute

People needed

23

Starts

2023-09-01

Expected to finish

2024-12-23

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• MedStar Lafayette Medical Centre — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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