Overactive BladderPhase 4NCT06695585
Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections
A Phase 4 study testing Lidocaine 2% without vessel constrictor in people with Overactive Bladder and Overactive Bladder Syndrome, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency
- What is being tested?
- Lidocaine 2% without vessel constrictor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laurel Carbone, MD contact
United States1 site
University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery
Louisville, Kentucky, 40202
About this study
Official title: Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial
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.
Read the detailed description
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.
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Frequency, Urge Incontinence, Neurogenic Bladder
- Being tested
- Lidocaine 2% without vessel constrictor
- Keywords
- Bladder Botox, Intravesical lidocaine, office Botox
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% without vessel constrictorDrug
Also called onabotulinum toxin
different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared
| Study group | Role | What they receive |
|---|---|---|
| Higher volume intravesical lidocaine | Active comparator | 200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox. Receives: 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. Receives: Drug: Lidocaine 2% without vessel constrictor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
- 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
Measured: on day of enrollment and procedure
Secondary outcomes (7)
Patient Global Impression of Severity (PGI-S)
Likert scale describing current severity of urinary tract condition: 1. Normal, 2. Mild, 3. Moderate, 4. Severe; higher scores indicate worse symptoms
Measured: through study completion, an average of 1 year
Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-Sat-q)
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.
Measured: 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)
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.
Measured: through study completion, an average of 1 year
Patient Global Impression of Improvement (PGI-I)
7-point Likert scale with 1 indicating "Very much better" and 7 indicating "Very much worse", lower scores indicate more improvement
Measured: through study completion, an average of 1 year
Bladder diary
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
Measured: through study completion, an average of 1 year
Post-void residual volume
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
Measured: through study completion, an average of 1 year
Adverse events
All adverse events will be recorded and tracked, including urinary tract infection, urinary retention, persistent hematuria, or additional suspected procedural related complications
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blinded, randomized superiority trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Francis, MD, University of Louisville
- Investigators
- Sean Francis, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695585
- Sponsor's protocol ID
- 24.0636
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share data with other researchers/outside affiliates
Publications
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.
PubMed 25754188
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT06695585
- Acronym / sponsor ID
- 24.0636
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Frequency, Urge Incontinence, Neurogenic Bladder
- Keywords
- Bladder Botox, Intravesical lidocaine, office Botox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, double-blinded, randomized superiority trial
| Arm | Type | Receives |
|---|---|---|
| Higher volume intravesical lidocaine | Active comparator | Drug: Lidocaine 2% without vessel constrictor200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox. |
| Lower volume intravesical lidocaine | Active comparator | Drug: Lidocaine 2% without vessel constrictor30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2% without vessel constrictorAlso: onabotulinum toxindifferent volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared | Drug | Higher volume intravesical lidocaine, Lower volume intravesical lidocaine |
Primary outcome
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
7 secondary outcomes
Patient Global Impression of Severity (PGI-S)
Time frame: through study completion, an average of 1 year
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
Patient Satisfaction Questionnaire Short-Form (PSQ-18)
Time frame: through study completion, an average of 1 year
Patient Global Impression of Improvement (PGI-I)
Time frame: through study completion, an average of 1 year
Bladder diary
Time frame: through study completion, an average of 1 year
Post-void residual volume
Time frame: through study completion, an average of 1 year
Adverse events
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 25754188Nambiar 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.
- Individual participant dataSharing planned: No. No plans to share data with other researchers/outside affiliates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurel Carbone, MD contact
Sean Francis, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine 2% without vessel constrictor in people with Overactive Bladder and Overactive Bladder Syndrome, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Francis, MD (502-588-7660, laurel.carbone@louisvill.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: on day of enrollment and procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.