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Optimal Lidocaine Volume for Pain Relief During Bladder Botox Injections

This study is looking at the best amount of lidocaine (a numbing medicine) to use in your bladder to reduce pain during office Botox injections for overactive bladder. Researchers want to compare two different volumes of 2% lidocaine: 200 ml versus 30 ml. You might be able to join if you are an adult woman (over 18), speak English, and have conditions like refractory urge urinary incontinence, refractory urinary urgency and frequency, or neurogenic bladder. The main goal is to see which volume of lidocaine provides better pain relief, measured by a Visual Analog Scale (VAS) on the day of enrollment and the procedure. The study plans to enroll 36 participants, but its current recruitment status is unclear.

Study design
This is a randomized, double-blind study comparing two different volumes of 2% lidocaine. It plans to enroll 36 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain levels will be measured on the day of enrollment and the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06695585

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

Not Yet Recruiting
PHASE4Ages 18+InterventionalSupportive care
University of Louisville
~36 participants
Updated 2024-11-19 on ClinicalTrials.gov
What's tested:Lidocaine 2% without vessel constrictor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analog Scale (VAS)
Measured over on day of enrollment and procedure

Conditions

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

Explore related trials

Neurogenic BladderOveractive BladderUrge incontinence of urine

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Sean Francis, MD · PRINCIPAL_INVESTIGATOR · University of Louisville

Who to contact

Sean Francis, MD
[email protected]
502-588-7660
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult female, \>18 years, English-speaking (surveys utilized are not validated in all languages)
Able to provide informed consent
Indications: Refractory urge urinary incontinence, Refractory urinary urgency and frequency, Neurogenic bladder (without sensory deficit)

Exclusion

Untreated urinary tract infection at the time of procedure
Contra-indication to Botox
Contraindication to intravesical lidocaine
Inability to provide informed consent
Pregnancy, breast-feeding, intending to become pregnant within 6 months of treatment

What this trial measures

  • Visual Analog Scale (VAS)on day of enrollment and procedure

    a. Determine the efficacy of pain relief via the Visual Analog Scale (VAS, scored 0-100 on 100 mm scale with 0 indicating no pain and 100 indicating the worst pain possible) in women randomized to 200 ml 2% lidocaine without epinephrine versus 30 ml 2% lidocaine without epinephrine prior to office intravesical onabotulinum toxin A (Botox) injections i. Perceived maximum VAS during the procedure and post-procedure ii. Superiority limit 20 mm on 100 mm VAS scale