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

September 21, 2022 updated by: Meryam El Issaoui, Herlev and Gentofte Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Region Hovedstaden
      • Herlev, Region Hovedstaden, Denmark, 2730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alkalinized Lidocaine, then Placebo

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.
Combination product: Alkalinized 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.
Drug: Placebo 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.
ACTIVE_COMPARATOR: Placebo, then 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.
Combination product: Alkalinized 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.
Drug: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-void residual requiring Clean Intermittent Catheterization (CIC)
Time Frame: Phone consultation one week after each treatment
The participant is contacted after each treatment and asked about any inability to empty the bladder
Phone consultation one week after each treatment
Urinary tract infection (UTI)
Time Frame: 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
Phone consultation one week after each treatment
Hematuria
Time Frame: Phone consultation one week after each treatment
The participant is contacted after each treatment and asked about blood in the urine
Phone consultation one week after each treatment
5-point rating scale
Time Frame: 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"
Phone consultation one week after each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev and Gentofte Hospital

Collaborators

Region Hovedstadens Apotek

Investigators

  • Study Director: Niels Klarskov, Prof,MD,DMSc, Herlev and Gentofte Hospital, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2022

Primary Completion (ANTICIPATED)

April 1, 2024

Study Completion (ANTICIPATED)

May 1, 2024

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (ACTUAL)

June 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTXA2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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