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

NCT06695585 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 24.0636
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Bladder Botox; Intravesical lidocaine; office Botox

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  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

  on day of enrollment and procedure

Secondary Outcomes (7)

• Patient Global Impression of Severity (PGI-S)

  through study completion, an average of 1 year

• Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q)

  This will be assessed pre and post-intervention for all participants through study completion, an average of 1 year

• Patient Satisfaction Questionnaire Short-Form (PSQ-18)

  through study completion, an average of 1 year

• Patient Global Impression of Improvement (PGI-I)

  through study completion, an average of 1 year

• Bladder diary

  through study completion, an average of 1 year

Study Arms (2)

Higher volume intravesical lidocaine

ACTIVE COMPARATOR

200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.

Drug: Lidocaine 2% without vessel constrictor

Lower volume intravesical lidocaine

ACTIVE COMPARATOR

30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.

Drug: Lidocaine 2% without vessel constrictor

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

Also known as: onabotulinum toxin

Higher volume intravesical lidocaine; Lower volume intravesical lidocaine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female anatomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Nambiar AK, Younis A, Khan ZA, Hildrup I, Emery SJ, Lucas MG. Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity. Neurourol Urodyn. 2016 Apr;35(4):522-7. doi: 10.1002/nau.22750. Epub 2015 Mar 8.

  PMID: 25754188 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Bladder, Neurogenic

Interventions

Lidocaine; onabotulinum toxin A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sean Francis, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Francis, MD

CONTACT

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

Laurel Carbone, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN Department Chair

Model Details: Prospective, double-blinded, randomized superiority trial

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)