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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Neha G Gaddam, MD
832-865-0244
neha.g.gaddam@medstar.net

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Neha G Gaddam, MD
832-865-0244
neha.g.gaddam@medstar.net

MedStar Lafayette Medical Centre
Washington, District of Columbia 20036
Contact:
Neha G Gaddam, MD
832-865-0244
neha.g.gaddam@medstar.net

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Neha G Gaddam, M.D.
832-865-0244
neha.g.gaddam@medstar.net

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.