Minimizing Pain During Office Intradetrussor Botox Injection

Overactive Bladder Clinical Trial

Official title:

Minimizing Pain During Office Intradetrussor Botox Injection: A Prospective Randomized Controlled Trial Comparing Two Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270526
• Other study ID #: 037-2019
• Status: Completed
• Phase: Phase 4
• Start date: August 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Boston Urogynecology Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperkinesis
• Overactive Bladder
• Overactive Bladder Syndrome
• Overactive Detrusor
• Overactivity; Behavior
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge

Intervention

Drug:
• Bicarbonate protocol
Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate
• Standard protocol
Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline

Locations

Country	Name	City	State
United States	Boston Urogynecology Associates	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: VAS	Pain on VAS	Immediately after the procedure
Secondary	Satisfaction: Likert scale	Likert scale questions assessing overall satisfaction with the procedure with responses from very dissatisfied to very satisfied	Immediately after the procedure
Secondary	Willingness to undergo repeat procedure	Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely to very unlikely	Immediately after the procedure
Secondary	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	Immediately after the procedure, 2 weeks post treatment
Secondary	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	Baseline, pre-procedure