Urge IncontinencePhase 3NCT05415865
The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder
A Phase 3 study testing Alkalinized Lidocaine in people with Urge Incontinence and Overactive Bladder, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urge Incontinence, Overactive Bladder, Anesthesia, Local
- What is being tested?
- Alkalinized Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Sep 2022to 1 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Kvinde- og Bækkenbundssygdomme, klinik 1
Herlev, Capital Region, 2730
Meryam El Issaoui, MD, +4553252379, Meryam.el.issaoui.01@regionh.dk
Niels Klarskov, Professor, DMSc, +4538681406, Niels.klarskov@regionh.dk
About this study
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
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.
Read the 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:
- Active drug: Lidocaine Hydrochloride and Sodium hydrogen carbonate
- 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
- Conditions
- Urge Incontinence, Overactive Bladder, Anesthesia, Local, Pain, Procedural, Urinary Tract Infections, Hematuria
- Being tested
- Alkalinized Lidocaine, Placebo Sodium Chloride 0.9% Inj
- Keywords
- Urge incontinence, Anesthesia, Local, Botulinum Toxins, Type A, Overactive Bladder, Alkalinized Lidocaine, Double-blind Method, Visual Analog Scale, Administration, Intravesical
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Pain, Procedural, Urinary Tract Infections, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkalinized LidocaineCombination product
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.
Placebo Sodium Chloride 0.9% InjDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Alkalinized Lidocaine, then Placebo | Active comparator | 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. Receives: Combination Product: Alkalinized Lidocaine; Drug: Placebo Sodium Chloride 0.9% Inj |
| Placebo, then Alkalinized Lidocaine | Active comparator | 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. Receives: Combination Product: Alkalinized Lidocaine; Drug: Placebo Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
100 mm Visual Analogue Scale (VAS) score
The maximum pain score reported by using VAS
Measured: 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 (4)
Post-void residual requiring Clean Intermittent Catheterization (CIC)
The participant is contacted after each treatment and asked about any inability to empty the bladder
Measured: Phone consultation one week after each treatment
Urinary tract infection (UTI)
The participant is contacted after each treatment and asked about symptoms of UTI: Dysuria, cloudy urine, pollakiuria, nocturia
Measured: Phone consultation one week after each treatment
Hematuria
The participant is contacted after each treatment and asked about blood in the urine
Measured: Phone consultation one week after each treatment
5-point rating scale
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"
Measured: Phone consultation one week after each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start12 Sep 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Hovedstadens Apotek
- Responsible party
- Principal investigator, Meryam El Issaoui, Herlev and Gentofte Hospital
- Investigators
- Niels Klarskov, Prof,MD,DMSc, Study director, Herlev and Gentofte Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415865
- Sponsor's protocol ID
- BTXA2021
- Status last verified
- Sep 2022
- First submitted
- 8 Jun 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
PubMed 19937315Vaughan CP, Johnson TM 2nd, Ala-Lipasti MA, Cartwright R, Tammela TL, Taari K, Auvinen A, Tikkinen KA. The prevalence of clinically meaningful overactive bladder: bother and quality of life results from the population-based FINNO study. Eur Urol. 2011 Apr;59(4):629-36. doi: 10.1016/j.eururo.2011.01.031. Epub 2011 Jan 25.
PubMed 21306820Irwin DE, Milsom I, Kopp Z, Abrams P; EPIC Study Group. Symptom bother and health care-seeking behavior among individuals with overactive bladder. Eur Urol. 2008 May;53(5):1029-37. doi: 10.1016/j.eururo.2008.01.027. Epub 2008 Jan 16.
PubMed 18243515Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, De Ridder D, Jenkins B, Magyar A, Chapple C; 191622-096 Investigators. Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. 2016 Sep;196(3):791-800. doi: 10.1016/j.juro.2016.03.146. Epub 2016 Mar 30.
PubMed 27038769Nambiar AK, Younis A, Khan ZA, Hildrup I, Emery SJ, Lucas MG. Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity. Neurourol Urodyn. 2016 Apr;35(4):522-7. doi: 10.1002/nau.22750. Epub 2015 Mar 8.
PubMed 25754188Nickel JC, Moldwin R, Lee S, Davis EL, Henry RA, Wyllie MG. Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. BJU Int. 2009 Apr;103(7):910-8. doi: 10.1111/j.1464-410X.2008.08162.x. Epub 2008 Nov 13.
PubMed 19021619Henry R, Patterson L, Avery N, Tanzola R, Tod D, Hunter D, Nickel JC, Morales A. Absorption of alkalized intravesical lidocaine in normal and inflamed bladders: a simple method for improving bladder anesthesia. J Urol. 2001 Jun;165(6 Pt 1):1900-3. doi: 10.1097/00005392-200106000-00014.
PubMed 11371877Narahashi T, Frazier T, Yamada M. The site of action and active form of local anesthetics. I. Theory and pH experiments with tertiary compounds. J Pharmacol Exp Ther. 1970 Jan;171(1):32-44. No abstract available.
PubMed 5410936Henry RA, Patterson L, Nickel C, Morales A. Alkalinized intravesical lidocaine to treat interstitial cystitis: absorption kinetics in normal and interstitial cystitis bladders. Urology. 2001 Jun;57(6 Suppl 1):119. doi: 10.1016/s0090-4295(01)01069-x. No abstract available.
PubMed 11378101Yanagi H, Sankawa H, Saito H, Iikura Y. Effect of lidocaine on histamine release and Ca2+ mobilization from mast cells and basophils. Acta Anaesthesiol Scand. 1996 Oct;40(9):1138-44. doi: 10.1111/j.1399-6576.1996.tb05577.x.
PubMed 8933856Pereira E Silva R, Ponte C, Lopes F, Palma Dos Reis J. Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2471-2479. doi: 10.1002/nau.24519. Epub 2020 Sep 21.
PubMed 32956506Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14.
PubMed 23246476Duthie JB, Vincent M, Herbison GP, Wilson DI, Wilson D. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD005493. doi: 10.1002/14651858.CD005493.pub3.
PubMed 22161392Dmochowski R, Chapple C, Nitti VW, Chancellor M, Everaert K, Thompson C, Daniell G, Zhou J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. J Urol. 2010 Dec;184(6):2416-22. doi: 10.1016/j.juro.2010.08.021. Epub 2010 Oct 16.
PubMed 20952013Cote TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005 Sep;53(3):407-15. doi: 10.1016/j.jaad.2005.06.011.
PubMed 16112345
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05415865
- Acronym / sponsor ID
- BTXA2021
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Region Hovedstadens Apotek
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Active drug: Lidocaine Hydrochloride and Sodium hydrogen carbonate
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alkalinized Lidocaine, then Placebo | Active comparator | Combination Product: Alkalinized Lidocaine, Drug: Placebo Sodium Chloride 0.9% InjParticipants 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 | Active comparator | Combination Product: Alkalinized Lidocaine, Drug: Placebo Sodium Chloride 0.9% InjParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alkalinized Lidocaine20 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. | Combination product | Alkalinized Lidocaine, then Placebo, Placebo, then Alkalinized Lidocaine |
| Placebo Sodium Chloride 0.9% Inj20 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. | Drug | Alkalinized Lidocaine, then Placebo, Placebo, then Alkalinized Lidocaine |
Primary outcome
100 mm Visual Analogue Scale (VAS) score
Time frame: 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
4 secondary outcomes
Post-void residual requiring Clean Intermittent Catheterization (CIC)
Time frame: Phone consultation one week after each treatment
Urinary tract infection (UTI)
Time frame: Phone consultation one week after each treatment
Hematuria
Time frame: Phone consultation one week after each treatment
5-point rating scale
Time frame: Phone consultation one week after each treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 19937315Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
- Background: PubMed 21306820Vaughan CP, Johnson TM 2nd, Ala-Lipasti MA, Cartwright R, Tammela TL, Taari K, Auvinen A, Tikkinen KA. The prevalence of clinically meaningful overactive bladder: bother and quality of life results from the population-based FINNO study. Eur Urol. 2011 Apr;59(4):629-36. doi: 10.1016/j.eururo.2011.01.031. Epub 2011 Jan 25.
- Background: PubMed 18243515Irwin DE, Milsom I, Kopp Z, Abrams P; EPIC Study Group. Symptom bother and health care-seeking behavior among individuals with overactive bladder. Eur Urol. 2008 May;53(5):1029-37. doi: 10.1016/j.eururo.2008.01.027. Epub 2008 Jan 16.
- Background: PubMed 27038769Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, De Ridder D, Jenkins B, Magyar A, Chapple C; 191622-096 Investigators. Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. 2016 Sep;196(3):791-800. doi: 10.1016/j.juro.2016.03.146. Epub 2016 Mar 30.
- Background: PubMed 25754188Nambiar AK, Younis A, Khan ZA, Hildrup I, Emery SJ, Lucas MG. Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: A prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity. Neurourol Urodyn. 2016 Apr;35(4):522-7. doi: 10.1002/nau.22750. Epub 2015 Mar 8.
- Background: PubMed 19021619Nickel JC, Moldwin R, Lee S, Davis EL, Henry RA, Wyllie MG. Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. BJU Int. 2009 Apr;103(7):910-8. doi: 10.1111/j.1464-410X.2008.08162.x. Epub 2008 Nov 13.
- Background: PubMed 11371877Henry R, Patterson L, Avery N, Tanzola R, Tod D, Hunter D, Nickel JC, Morales A. Absorption of alkalized intravesical lidocaine in normal and inflamed bladders: a simple method for improving bladder anesthesia. J Urol. 2001 Jun;165(6 Pt 1):1900-3. doi: 10.1097/00005392-200106000-00014.
- Background: PubMed 5410936Narahashi T, Frazier T, Yamada M. The site of action and active form of local anesthetics. I. Theory and pH experiments with tertiary compounds. J Pharmacol Exp Ther. 1970 Jan;171(1):32-44. No abstract available.
- Background: PubMed 11378101Henry RA, Patterson L, Nickel C, Morales A. Alkalinized intravesical lidocaine to treat interstitial cystitis: absorption kinetics in normal and interstitial cystitis bladders. Urology. 2001 Jun;57(6 Suppl 1):119. doi: 10.1016/s0090-4295(01)01069-x. No abstract available.
- Background: PubMed 8933856Yanagi H, Sankawa H, Saito H, Iikura Y. Effect of lidocaine on histamine release and Ca2+ mobilization from mast cells and basophils. Acta Anaesthesiol Scand. 1996 Oct;40(9):1138-44. doi: 10.1111/j.1399-6576.1996.tb05577.x.
- Background: PubMed 32956506Pereira E Silva R, Ponte C, Lopes F, Palma Dos Reis J. Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2471-2479. doi: 10.1002/nau.24519. Epub 2020 Sep 21.
- Background: PubMed 23246476Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14.
- Abrams P, Cardozo, L, Wagg, A, Wein, A. (Eds) Incontinence 6th Edition. International Continence Society, Bristol UK,: ICI-ICS.; 2017Link provided by the sponsor.
- Incontinence. International Consultation on Incontinence: ICUD; 2017Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Klarskov, Prof,MD,DMSc study director
Herlev and Gentofte Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alkalinized Lidocaine in people with Urge Incontinence and Overactive Bladder, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meryam El Issaoui, MD (+4553252379, meryam.el.issaoui.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100 mm Visual Analogue Scale (VAS) score (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415865, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.