Not Yet RecruitingPhase 4

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

United States36 participantsStarted 2024-12-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 they're measuring

Visual Analog Scale (VAS)

Timeframe: on day of enrollment and procedure

Trial details

NCT IDNCT06695585

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

Contact for this trial

Sean Francis, MD

502-588-7660 laurel.carbone@louisvill.edu

View on ClinicalTrials.gov More Overactive Bladder trials