Clinical trial NCT05415865: The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder
Official title: The Effect of Intravesical Lidocaine Solution Versus Placebo as Anesthesia Prior to Intravesical Injection of Onabotulinum Toxin A. A Randomized, Double-blind, Placebo Controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Urge Incontinence
Overactive Bladder
Anesthesia, Local
Pain, Procedural
Urinary Tract Infections
Hematuria
Keywords: Urge incontinence
Anesthesia, Local
Botulinum Toxins, Type A
Overactive Bladder
Alkalinized Lidocaine
Double-blind Method
Visual Analog Scale
Administration, Intravesical
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Region Hovedstadens Apotek
First posted: 2022-06-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a randomized, controlled, double-blinded, crossover study. The participants are their own control in the evaluation of the effect of intravesical alkalinized Lidocaine solution versus placebo as anesthesia prior to intravesical injection of onabotulinum toxin A. The chosen model is advantageous as a smaller sample size is needed, and error variance is reduced.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 100 mm Visual Analogue Scale (VAS) score
timeFrame: The participant is handed the VAS in paper form and asked to grade the intensity of pain according to the VAS by making a handwritten mark on the VAS immediately after the BTX-A injections
Secondary outcomes:
measure: Post-void residual requiring Clean Intermittent Catheterization (CIC)
timeFrame: Phone consultation one week after each treatment
measure: Urinary tract infection (UTI)
timeFrame: Phone consultation one week after each treatment
measure: Hematuria
timeFrame: Phone consultation one week after each treatment
measure: 5-point rating scale
timeFrame: Phone consultation one week after each treatment
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Kvinde- og Bækkenbundssygdomme, klinik 1
state: Region Hovedstaden
Study officials:
affiliation: Herlev and Gentofte Hospital, University of Copenhagen
name: Niels Klarskov, Prof,MD,DMSc
role: STUDY_DIRECTOR
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