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TERMINATEDNANCT06043063

Local Anesthesia Before Bulkamid Injection

While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with...

Lead sponsor: Medstar Health Research Institute•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Medstar Health Research Institute

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 16, 2025Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment23

Start dateSep 2023

Last updatedMay 16, 2025

Condition

Stress Urinary Incontinence Intrinsic Sphincter Deficiency

Locations shown

MedStar Georgetown University Hospital

Washington D.C., District of Columbia

MedStar Washington Hospital Center

Washington D.C., District of Columbia

MedStar Lafayette Medical Centre

Washington D.C., District of Columbia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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