Evaluation of Efficacy and Patient Satisfaction of Local Anaesthesia Versus Sedoanalgesia for Botox (R) Injection in the Urinary Bladder for the Treatment of Idiopathic Overactive Bladder (LA vs SA)

May 26, 2024 updated by: Hospital LKH Hochsteiermark - Leoben

Evaluation of Efficacy and Patient Satisfaction Using Local Anaesthesia Versus Sedoanalgesia for Intradetrusor Botulinum-Toxin A Injection for the Treatment of Idiopathic Overactive Bladder: a Randomized Controlled Non-inferiority Trial

Patients with symptoms of overactive bladder suffer from frequent micturition, urinary incontinence and recurrent urinary tract infections. Intravesical injections with botulinum toxin A can be used as a second-line therapy for this purpose.

Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region.

As these patients are often elderly and morbid, the lowest-risk and least stressful anesthesia method should be used. The lowest-risk anesthesia method that can be used is local anesthesia. Currently, there are no guidelines that describe the use of standardized protocols for local anesthesia.

The aim of this study is to show that the use of local anesthesia in this context is not inferior to the use of sedoanalgesia.

All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study.

The main outcome measure is pain, secondary outcome measures are quality of life, patient satisfaction, incontinence score, operation time and length of stay in the recovery room, acceptance of repeating the procedure under local anesthesia, satisfaction with the type of anesthesia method, side effects/complications and duration of inpatient stay.

The study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio to carry out the intravesical injection with botulinum toxin A.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Urinary urgency symptoms with frequent micturition, urinary incontinence, nocturia and recurrent urinary tract infections are typical complaints of women with symptoms of an overactive bladder. The level of suffering is usually very high. Social withdrawal, depressive moods, frequent antibiotic use and financial burdens due to the increased need for incontinence products can be the result. In accordance with the guideline-based treatment of idiopathic overactive bladder, intravesical injection of botulinum toxin A can be offered after unsuccessful conservative first-line and second-line treatment. Intravesical injection of botulinum toxin A has been approved for the treatment of idiopathic overactive bladder in Austria since 2013. Botulinum toxin A is a registered drug in Austria and is used for injection into the detrusor with 100IE according to its approval indication.

Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region. The effectiveness of botulinum toxin A is limited in time. Injections are repeated on average after 6-12 months. Patients are often older and often have comorbidities. Due to this and the potential need for repeated applications, the procedure should be performed under general and regional anesthesia. The use of local anesthesia, as one of the anesthesia methods mentioned, is considered to be very low-risk and the least stressful overall.

Comparing the use of local anesthesia with the use of sedoanalgesia to perform the botulinum toxin A injection is equivalent to comparing two guideline-compliant standard treatments. The confirmation of our hypothesis, namely that performing the procedure under local anesthesia is equivalent to performing it under sedoanalgesia (non-inferiority study), could serve to optimize the treatment of overactive bladder patients and contribute to an increase in the level of health protection by strengthening the role of local anesthesia in the context of this procedure as an efficient option with the elimination of all anesthetic risks and as a first-choice procedure.

All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study.

The following examinations are carried out on all patients before inclusion, in accordance with the examination standard of our department:

  • Medical history: age, micturition frequency day/night, urinary leakage, sexuality, amount drunk, frequency of urinary tract infections, previous treatments for incontinence, parity, secondary diseases (diabetes mellitus, obesity, arterial hypertension, central nervous diseases, etc), previous gynecological operations, medication
  • Urogynecological examination
  • Urinalysis (midstream urine)
  • Urodynamics with stress test
  • Micturition protocol (will be scanned)
  • Standardized questionnaires to assess incontinence symptoms and quality of life

This is an open prospective randomized controlled non-inferiority study. Patients participating in the study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio. Randomization will be done electronically (www.randomizer.at).

The sample design was calculated based on a non-inferiority study with pain score evaluation as the primary endpoint.

A sample size of 39 per group, including expected drop-outs (approximately 3 per group) results in a required number of participants of 84.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Austria
      • Leoben, Austria, 8700
        • LKH Hochsteiermark

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women with a minimum age of 18 years; no maximum age
  • Unsuccessful conservative first and second-line treatment of OAB (defined as: completed pelvic floor/bladder training, local estrogenization of the vagina, at least one anticholinergic or ß3-mimetic oral therapy)
  • Good German language skills

Exclusion Criteria:

  • Pregnant women, breastfeeding women (no indication for approval)
  • Women unable to give informed consent
  • Refusal to participate in the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: local anaesthesia
Drug: intravesical botulinum toxin A injection unter local anaesthesia

Arm1: Botulinum toxin A injection under local anesthesia according to standard protocol:

Retrograde filling of the empty urinary bladder with a 1:1 mixture of 50 ml lidocaine 1% mixed with 50 ml sodium bicarbonate 8.4%, leave the local anesthetic mixture in the bladder for 15 minutes.

Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10 ml NaCl 0.9% into the detrusor at 10 points using a rigid 70 degree cystoscope

Arm 2: botulinum toxin A injection in sedoanalgesia according to the anesthesia standard protocol:

Intravenous administration of remifentanil (0.05-0.15µg/kg/min) and propofol. Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10ml NaCl 0.9% into the detrusor.
Active Comparator: sedoanalagesia
Drug: intravesical botulinum toxin A injection unter local anaesthesia

Arm1: Botulinum toxin A injection under local anesthesia according to standard protocol:

Retrograde filling of the empty urinary bladder with a 1:1 mixture of 50 ml lidocaine 1% mixed with 50 ml sodium bicarbonate 8.4%, leave the local anesthetic mixture in the bladder for 15 minutes.

Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10 ml NaCl 0.9% into the detrusor at 10 points using a rigid 70 degree cystoscope

Arm 2: botulinum toxin A injection in sedoanalgesia according to the anesthesia standard protocol:

Intravenous administration of remifentanil (0.05-0.15µg/kg/min) and propofol. Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10ml NaCl 0.9% into the detrusor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain assessed by numeric rating scale
Time Frame: twentyfour hours
The numeric rating scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and ten meaning "the worst pain imaginable".
twentyfour hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction assessed with postoperative anaesthesia questionnaire
Time Frame: twentyfour hours
The postoperative anaesthesia questionnaire is a tool used to assess a patient's experience with anesthesia following surgery. It aims to gather information about the patient's perceptions of anesthesia-related outcomes and any adverse effects they may have experienced. It collects direct feedback from patients about their subjective experiences, including satisfaction and any discomfort or complications. Common sections and questions are about preoperative information, intraoperative experience, postoperative symptoms and overall satisfaction. Questions are answered with "yes" or "no".
twentyfour hours
quality of life assessed with King's Health Questionnaire
Time Frame: three and twelve months
The King's Health Questionnaire is a disease specific, self-administered questionnaire designed to assess the impact of urinary incontinence on quality of life in women. The questions in this questionnaire are to be answered using a 0-4 scale, with zero meaning "not applicable" and four meaning "very accurate".
three and twelve months

Collaborators and Investigators

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

Sponsor

Hospital LKH Hochsteiermark - Leoben

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

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 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21346
  • AUB (Other Identifier: AUB - Arbeitsgemeinschaft für Urogynäkologie Österreich)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The important and interesting data are published in a journal as part of the publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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