NCT06437899: LA vs SA

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

ENROLLING BY INVITATION NA Last updated 26 May 2024

What this trial tests

NA trial testing intravesical botulinum toxin A injection unter local anaesthesia in Overactive Bladder in 84 participants. Enrolling by invitation.

Timeline

1 September 2023

Primary endpoint
1 September 2026

1 September 2027

Quick facts

Lead sponsor	Hospital LKH Hochsteiermark - Leoben
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	1 September 2023
Primary completion	1 September 2026
Estimated completion	1 September 2027
Sites	1 location across Austria

Drugs / interventions tested

• intravesical botulinum toxin A injection unter local anaesthesia — full drug profile →

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Hospital LKH Hochsteiermark - Leoben

Who can join

18 and older, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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".

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.