Local Anesthesia Before Bulkamid Injection

Medstar Health Research Institute23 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stress Urinary Incontinence Intrinsic Sphincter Deficiency

Interventions

Topical lidocainePROCEDURE

Topical anesthetic

EMLA creamPROCEDURE

Topical anesthetic

Periurethral blockPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Visual analog scale (VAS) for pain

Visual analog scale for pain uses a scale from 0-10 corresponding to reported pain levels with 0 indicating no pain and 10 indicating most severe pain possible

Time frame: Ascertained at end of procedure (withdrawal of cystoscope)

Secondary Outcomes

Duration of procedure

in seconds

Time frame: Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)

Incomplete bladder emptying

Inability to void after procedure

Time frame: Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)

Need for re-injection of PAHG

Requirement for "top-off" or repeat injection due to persistent symptoms

Time frame: Assessed at follow-up 2 weeks post-procedure

International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)

3 items on frequency/quantity of leakage and impact on quality on life (range 0-21 with lower score indicating lower severity of incontinence symptoms and higher score indicating higher severity of incontinence symptoms)

Time frame: Assessed at baseline and at two-week and twelve-week follow-up visit

Patient Global Impression of Improvement scale (PGI-I)

1 item on relative change in symptoms following treatment (range 1-7 with lower score indicating greater improvement in incontinence symptoms following intervention and higher score indicating lower improvement in incontinence following intervention)

Time frame: Assessed at two-week and twelve-week follow-up visit

Data from ClinicalTrials.gov

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