The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder
- Conditions
- Urge IncontinenceOveractive BladderAnesthesia, LocalPain, ProceduralHematuriaUrinary Tract Infections
- Interventions
- Combination Product: Alkalinized LidocaineDrug: Placebo Sodium Chloride 0.9% Inj
- Registration Number
- NCT05415865
- Lead Sponsor
- Herlev and Gentofte Hospital
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Alkalinized Lidocaine, then Placebo Alkalinized Lidocaine 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. Alkalinized Lidocaine, then Placebo Placebo Sodium Chloride 0.9% Inj 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. Placebo, then Alkalinized Lidocaine Alkalinized Lidocaine 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. Placebo, then Alkalinized Lidocaine Placebo Sodium Chloride 0.9% Inj 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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"
Trial Locations
- Locations (1)
Kvinde- og Bækkenbundssygdomme, klinik 1
🇩🇰Herlev, Region Hovedstaden, Denmark