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NCT Number: NCT06695585

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urge Incontinence Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urinary Frequency Urinary Incontinence Urinary Incontinence, Urge Urinary Urgency Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Louisville, Kentucky, 40202, United States

About this study

The volume of 2% intravesical lidocaine solution and efficacy for pain relief at the time of office intradetrusor Botox A injection has not been well studied. Studies evaluating intravesical lidocaine show that it is not sufficiently absorbed by human bladders to achieve serum toxicity levels and only provides superficial local anesthetic effect. Experts agree that intravesical local anesthetic can be given in the office, with approximately 30 to 40 mL of 2% lidocaine instilled via catheter into the bladder for about 20 minutes before injection. However, there is little evidence regarding this strategy, and future research would help standardize recommendations.

The purpose of our study is to evaluate the efficacy and safety of higher volume pre-procedure intravesical lidocaine solution for pain at the time of intradetrusor office 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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: onabotulinum toxin

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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

Secondary outcomes

  1. Patient Global Impression of Severity (PGI-S)

    Time frame: through study completion, an average of 1 year

    Likert scale describing current severity of urinary tract condition: 1. Normal, 2. Mild, 3. Moderate, 4. Severe; higher scores indicate worse symptoms

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

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

    An 11-item questionnaire that assesses patient satisfaction with their overactive bladder (OAB) treatment. It includes three sub-scales (satisfaction, side effects, and endorsement) and two single-item assessments (convenience and preference). Scores range from 0-100, higher scores indicate higher satisfaction with treatment. Used to assess treatment satisfaction over time.

  3. Patient Satisfaction Questionnaire Short-Form (PSQ-18)

    Time frame: through study completion, an average of 1 year

    An 8-item question assessing satisfaction with medical care experience, measured on a Likert scale with 1 "Strongly agree" and 5 "Strongly disagree", for questions 1-3, 5-6, and 8 lower scores indicate higher satisfaction. For questions 4 and 7 lower scores indicate dissatisfaction.

  4. Patient Global Impression of Improvement (PGI-I)

    Time frame: through study completion, an average of 1 year

    7-point Likert scale with 1 indicating "Very much better" and 7 indicating "Very much worse", lower scores indicate more improvement

  5. Bladder diary

    Time frame: through study completion, an average of 1 year

    3-day bladder diary with objective patient reported data reporting voids per day, frequency between voids (measured in minutes or hours), episodes of incontinence per day

  6. Post-void residual volume

    Time frame: through study completion, an average of 1 year

    Measure voided volume and obtain post-void residual volume either by bladder scan or straight catheterization in the office at 2-week follow up appointment (or additional time points if indicated) following bladder Botox injection

  7. Adverse events

    Time frame: through study completion, an average of 1 year

    All adverse events will be recorded and tracked, including urinary tract infection, urinary retention, persistent hematuria, or additional suspected procedural related complications

Study contacts

Contact information is provided by the study sponsor or research team.

Laurel Carbone, MD

CONTACT

Sean Francis, MD

CONTACT

[email protected]

502-588-7660

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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