Anesthesia, Local, Hematuria, Overactive Bladder, Pain, Procedural, Urge Incontinence, Urinary Tract Infections
Conditions
Keywords
Urge incontinence, Anesthesia, Local, Botulinum Toxins, Type A, Overactive Bladder, Alkalinized Lidocaine, Double-blind Method, Visual Analog Scale, Administration, Intravesical
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
Interventions
DRUGPlacebo Sodium Chloride 0.9% Inj
20 ml of Sodium Chloride 9 g/L and 10 ml of Sodium Chloride 9 g/L will be pulled up and mixed in a syringe on site, and 30 ml solution in total will afterwards be installed in the bladder with a catheter.
COMBINATION_PRODUCTAlkalinized Lidocaine
20 ml of Lidocaine Hydrochloride and 10 ml of Sodium hydrogen carbonate will be pulled up and mixed in a syringe on site, and 30 ml mixed solution in total will afterwards be installed in the bladder with a catheter.
Sponsors
Region Hovedstadens Apotek
Herlev and Gentofte Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Region Hovedstadens Apotek, Herlev Hospital produces the Lidocaine solution and the matching placebo solution, performs the randomization, and packages the blinded dosing kits with the order of Lidocaine and placebo in a balanced design (50% Lidocaine at the first treatment). Participants will get consecutive randomization numbers, which specify the dosing kit. Neither the participant, the operator, or the healthcare professional interviewing the participant about her pain score know what solution the participant gets administered.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 100 mm Visual Analogue Scale (VAS) score | 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 | The maximum pain score reported by using VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-void residual requiring Clean Intermittent Catheterization (CIC) | Phone consultation one week after each treatment | The participant is contacted after each treatment and asked about any inability to empty the bladder |
| Urinary tract infection (UTI) | Phone consultation one week after each treatment | The participant is contacted after each treatment and asked about symptoms of UTI: Dysuria, cloudy urine, pollakiuria, nocturia |
| Hematuria | Phone consultation one week after each treatment | The participant is contacted after each treatment and asked about blood in the urine |
| 5-point rating scale | Phone consultation one week after each treatment | The participant is contacted one week after every treatment and asked about the experience on the procedure. The participant's experience on the procedure on a 5-point ordinal scale: 1- very unsatis-fied, 2- unsatisfied, 3- neither unsatisfied or satisfied, 4- satisfied, 5-very satisfied |
Countries
Denmark
Contacts
Primary ContactMeryam El Issaoui, MD
Backup ContactNiels Klarskov, Prof,MD,DMSc
Outcome results
None listed