Status:
TERMINATED
Local Anesthesia Before Bulkamid Injection
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Stress Urinary Incontinence
Intrinsic Sphincter Deficiency
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06043063
Start Date
September 1 2023
End Date
December 23 2024
Last Update
May 16 2025
Active Locations (3)
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1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
MedStar Lafayette Medical Centre
Washington D.C., District of Columbia, United States, 20036