Minimizing Pain During Office Intradetrussor Botox Injection
Primary Purpose
Overactive Bladder, Overactive Detrusor, Overactive Bladder Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bicarbonate protocol
Standard protocol
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- Female patient
- Primary diagnosis of overactive bladder
- Failed first and second line therapy for overactive bladder
- Planning to undergo bladder botox injections
Exclusion Criteria:
- Neurogenic bladder
- Urinary retention
Sites / Locations
- Boston Urogynecology Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active treatment
Placebo treatment
Arm Description
50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate
50 mL 1% lidocaine + 50ml of 0.9% normal saline
Outcomes
Primary Outcome Measures
Pain: VAS
Pain on VAS
Secondary Outcome Measures
Satisfaction: Likert scale
Likert scale questions assessing overall satisfaction with the procedure with responses from very dissatisfied to very satisfied
Willingness to undergo repeat procedure
Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely to very unlikely
Adverse events
Urinary retention, defined as a post-void residual of greater than 100cc, will be assessed with a bladder scan at the two week post-procedure appointment
Pelvic Floor Distress Inventory (PFDI-20) Scores
baseline Pelvic Floor Distress Inventory (PFDI-20), scores range from 0-300 with higher scores representing higher symptom burden
Full Information
NCT ID
NCT04270526
First Posted
February 12, 2020
Last Updated
July 26, 2023
Sponsor
Boston Urogynecology Associates
1. Study Identification
Unique Protocol Identification Number
NCT04270526
Brief Title
Minimizing Pain During Office Intradetrussor Botox Injection
Official Title
Minimizing Pain During Office Intradetrussor Botox Injection: A Prospective Randomized Controlled Trial Comparing Two Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Urogynecology Associates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This will be a prospective double-blinded randomized controlled trial comparing two pre-treatment protocols for patients undergoing intradetrussor botox injections to determine if a buffered lidocaine solution offers superior pain control.
Detailed Description
Lidocaine is a commonly used amide-type local anesthetic. Lidocaine exists as both a quaternary water soluble structure, and a tertiary lipid-soluble structure. Only the tertiary lipid-soluble structure can cross the lipid bilayer of a cell membrane and thereby enter a neurons axoplasm and induce the desired effect. The ionization constant of lidocaine is 7.7 which means that at a pH of 7.7, 50% of lidocaine is available in the tertiary lipid-soluble structure. At a physiologic pH between 7.35 and 7.45 only around 44% of lidocaine is in the tertiary lipid-soluble structure. However, for lidocaine to be stable in solution, it is typically formulated as a hydrochloride salt and the pH of most commercially available lidocaine solutions are at a pH of 6.09. In an acidic solution the majority of lidocaine is available in the quaternary water-soluble structure and at this pH only 2.5% of lidocaine is in the tertiary lipid-soluble structure. A Cochrane review found that increasing the pH of lidocaine prior to injection decreased pain and increased patient satisfaction perhaps because of the aforementioned pharmacokinetic principles.
Lidocaine is typically used as anesthetic for intradetrussor injections of onabotulinum toxin A for the treatment of refractory overactive bladder. In 2003, a technique for intradetrussor injections of onabotulinum toxin A was first described using only local anesthesia. At that time, the procedure involved intrauerthral lidocaine. The procedure has evolved since that time and currently many physicians utilize protocols with both utraurethral and intravesical lidocaine. At baseline intradetrusor onabotulinum toxin A injections are generally well tolerated and with reported mean VAS scores around 3.
For patients with refractory overactive bladder, the standard of care is intradetrussor onabotulinum toxin A injections. The standard protocol used by the investigators involves emptying the bladder then retrograde filling the bladder with a 1:1 mixture of 1% lidocaine normal saline. This solution remains in the bladder for approximately 15 minutes prior to injection. Given that urine is typically acidic and commercially available lidocaine solutions are similarly acidic, it is likely that only a fraction of intravesical lidocaine is in the active tertiary lipid-soluble form. The goal of this study is to determine if the investigators can improve the procedural pain of intradetrusor onabotulinum toxin A injections using a buffered solution compared to our standard solution.
After approval by the IRB, investigators will approach possible participants who are having intradetrussor botox injection for overactive bladder which is the standard of care for patients with refractory overactive bladder. If the patient meets eligibility criteria, consent forms will be signed and the patient will be randomized 1:1 to receive either our standard pretreatment regimen with 50 mL 1% lidocaine + 50ml of 0.9% normal saline or our buffered bicarbonate protocol with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate. The primary end point of this trial is to assess the pain scores measured on a Visual Analogue Scale (VAS) immediately following the procedure. Secondary end points include patient satisfaction, willingness to undergo repeat treatment and adverse events.
All subjects will be randomized 1:1 at the first intervention visit to one of the two protocols using a random block design . At the completion of the procedure, patients will be asked to complete a brief questionnaire about their experience. Patients will follow up in clinic for a post-void residual check two weeks after the procedure as is standard for our clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Overactive Detrusor, Overactive Bladder Syndrome, Overactivity; Behavior, Urge Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
All subjects will be randomized 1:1 at the first intervention visit to one of the two protocols using a random block design
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Active Comparator
Arm Description
50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
50 mL 1% lidocaine + 50ml of 0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
Bicarbonate protocol
Intervention Description
Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate
Intervention Type
Drug
Intervention Name(s)
Standard protocol
Intervention Description
Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline
Primary Outcome Measure Information:
Title
Pain: VAS
Description
Pain on VAS
Time Frame
Immediately after the procedure
Secondary Outcome Measure Information:
Title
Satisfaction: Likert scale
Description
Likert scale questions assessing overall satisfaction with the procedure with responses from very dissatisfied to very satisfied
Time Frame
Immediately after the procedure
Title
Willingness to undergo repeat procedure
Description
Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely to very unlikely
Time Frame
Immediately after the procedure
Title
Adverse events
Description
Urinary retention, defined as a post-void residual of greater than 100cc, will be assessed with a bladder scan at the two week post-procedure appointment
Time Frame
Immediately after the procedure, 2 weeks post treatment
Title
Pelvic Floor Distress Inventory (PFDI-20) Scores
Description
baseline Pelvic Floor Distress Inventory (PFDI-20), scores range from 0-300 with higher scores representing higher symptom burden
Time Frame
Baseline, pre-procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patient
Primary diagnosis of overactive bladder
Failed first and second line therapy for overactive bladder
Planning to undergo bladder botox injections
Exclusion Criteria:
Neurogenic bladder
Urinary retention
Facility Information:
Facility Name
Boston Urogynecology Associates
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Minimizing Pain During Office Intradetrussor Botox Injection
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