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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
Overactive Bladder
Interventions
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."

Trial Locations (1)

8700

LKH Hochsteiermark, Leoben

All Listed Sponsors
lead

Hospital LKH Hochsteiermark - Leoben

OTHER