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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
Sponsor: Hospital LKH Hochsteiermark - Leoben
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2023-09-01
Completion Date
2027-09
Last Updated
2024-05-31
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
LKH Hochsteiermark
Leoben, Austria