Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT06695585
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Neurogenic Bladder
  • Overactive Bladder
  • Overactive Bladder Syndrome
  • Urge Incontinence
  • Urinary Frequency
  • Urinary Urgency

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine 2% without vessel constrictor — DRUG
    different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared

Study Details

The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

Key Dates

Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Jun 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Higher volume intravesical lidocaine
    200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.
  • Active Comparator: Lower volume intravesical lidocaine
    30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.

Primary Outcome Measure

Visual Analog Scale (VAS) [ Time Frame: on day of enrollment and procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Louisville Division of Urogynecology and Reconstructive Pelvic SurgeryLouisvilleKentucky40202-

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University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery· Louisville, KY

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