The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder

Herlev and Gentofte Hospital

Status and phase: Enrolling; Phase 3

Conditions: Urinary Tract Infections; Anesthesia, Local; Hematuria; Pain, Procedural; Overactive Bladder; Urge Incontinence

Treatments: Combination Product: Alkalinized Lidocaine; Drug: Placebo Sodium Chloride 0.9% Inj

Study type: Interventional

Funder types: Other

Identifiers

NCT05415865

BTXA2021

Details and patient eligibility

About

The purpose of this study is to investigate the effect of Lidocaine solution versus placebo (isotonic Sodium Chloride NaCl) disposed inside the urinary bladder as intravesical anesthesia prior to onabotulinum toxin A injections in the treatment of urgency urinary incontinence.

Full description

The aim of the study is to investigate if bladder installed Lidocaine solution have an effect on reported pain during BTX-A injections compared to placebo.

The study participants will be recruited from the existing patient populations enrolled in the BTX-A program of the tertiary Urogynaecological Clinic of Herlev University Hospital.

The participants are randomized to:

1. Active drug: Lidocaine Hydrochloride and Sodium hydrogen carbonate
2. Placebo: Sodium Chloride

The study includes 5 study visits:

Visit 1:

• First treatment day
• Randomization
• Registration of pre-treatment pain relief medications: paracetamol, ibuprofen, or other medications. If pre-treatment pain relief is taken before first treatment, same pain relief should be taken before second treatment day (visit 4) in order to reduce bias
• Registration of antibiotic treatment: current antibiotic treatment or long-term prophylactic antibiotic for prevention of recurrent UTI The participant receives the active treatment or placebo, double-blinded
• The participant is asked to grade the intensity of pain according to VAS score immediately after, and when participant has been dressed after the BTX-A injections

Visit 2 (by telephone):

• Phone consultation 1 week after treatment:
• The participant's experience on the procedure on a 5-point ordinal scale: "1- very unsatisfied", "2- unsatisfied", "3- neither unsatisfied or satisfied", "4- satisfied", "5-very satisfied"

Side effects:

• Questions on symptoms of UTI: dysuria, cloudy urine, pollakiuria, nocturia
• Hematuria
• Inability to empty the bladder
• Other symptoms

(Visit 3:)

• The participant contacts the Clinic for next treatment approximately 6-12 months later
• Sponsor or investigator from the Urogynecological Clinic reach out for the participant asking on symptoms of UUI if the participant has not contacted the clinic within 12 months

Visit 4:

• Second treatment day
• The participant receives the opposite treatment, still double-blinded
• Registration of pre-treatment pain relief medications: paracetamol, ibuprofen, or other medications
• Registration of antibiotic treatment: current antibiotic treatment or long-term prophylactic antibiotic for prevention of recurrent UTI
• The participant is asked to grade the intensity of pain according to VAS score immediately after, and when participant has been dressed after the BTX-A injections

Visit 5(by telephone):

• Phone consultation 1 week after treatment:
• The participant's experience on the procedure on a 5-point scale: "1- very unsatisfied", "2- unsatisfied", "3- neither unsatisfied or satisfied", "4- satisfied", "5-very satisfied"

Side effects:

• Questions on symptoms of UTI: dysuria, cloudy urine, pollakiuria nocturia,
• Hematuria
• Inability to empty the bladder
• Other symptoms

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female, age ≥18 years
• Admitted to treatment with BTX-A injections at the Urogynecological Clinic at Herlev Hospital due to UUI
• Able to read and understand Danish
• The female accepts to receive BTX-A injections as an outpatient treatment without the option of receiving sedative drugs

Exclusion criteria

• BTX-A allergy
• Neurological disorder that may affect bladder function (e.g. Multiple sclerosis or spinal cord inju-ry)
• Neurological disorder with neuromuscular transmission failure (i.e. Mystenia Gravis)
• Ongoing UTI or symptoms of UTI prior to treatment, assessed by principal investigator
• Any other bladder pathology at the time of cystoscopy if identified (includes trauma, stones, tu-mor)
• Pregnancy/breastfeeding women

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Alkalinized Lidocaine, then Placebo

Active Comparator group

Description:

Participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure. When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have the matching placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder for 15 minutes prior to the BTXA-injection procedure.

Treatment:

Combination Product: Alkalinized Lidocaine

Drug: Placebo Sodium Chloride 0.9% Inj

Placebo, then Alkalinized Lidocaine

Active Comparator group

Description:

Participants will have placebo containing Sodium Chloride 9 g/L, 20 ml and Sodium Chloride 9 g/L, 10 ml, a total of 30 ml installed in the bladder 15 minutes prior to the BTXA-injection procedure. When signing up for the next BTXA-injection with a wash out period of minimum three months, participants will have Lidocaine Hydrochloride 20 mg/ml, 20 ml and Sodium hydrogen carbonate 1 mmol/ml, 10 ml (ie a total of 30 ml) installed in the bladder for 15 minutes prior to the BTXA-injection procedure.

Treatment:

Combination Product: Alkalinized Lidocaine

Drug: Placebo Sodium Chloride 0.9% Inj