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
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- What is being studied
- The protocol lists: intravesical botulinum toxin A injection unter local anaesthesia.
- Who it may be relevant to
- Registry conditions: Overactive Bladder. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
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 se
Primary outcome measures
- pain assessed by numeric rating scale [Time frame: twentyfour hours]
Secondary outcome measures (2)
- patient satisfaction assessed with postoperative anaesthesia questionnaire [Time frame: twentyfour hours]
- quality of life assessed with King's Health Questionnaire [Time frame: three and twelve months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- LKH Hochsteiermark — Leoben
Publications
- Subramanian B, Shastri N, Aziz L, Gopinath R, Karlekar A, Mehta Y, Sharma A, Bapat JS, Jain P, Jayant A, Samra T, Perera A, Agarwal A, Shetty V, Bhatnagar S, Pandya ST, Jain P. ASSIST - Patient satisfaction survey in postoperative pain management from Indian subcontinent. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):40-47. doi: 10.4103/joacp.JOACP_245_16. PMID 28413271
- Smith I, Avramov MN, White PF. A comparison of propofol and remifentanil during monitored anesthesia care. J Clin Anesth. 1997 Mar;9(2):148-54. doi: 10.1016/S0952-8180(96)00240-1. PMID 9075041
- Barba M, Lazar T, Cola A, Marino G, Manodoro S, Frigerio M. Learning Curve of Botulinum Toxin Bladder Injection for the Treatment of Refractory Overactive Bladder. Int J Womens Health. 2022 Jan 4;14:1-7. doi: 10.2147/IJWH.S345454. eCollection 2022. PMID 35018123
- Schurch B, Reitz A, Tenti G. Electromotive drug administration of lidocaine to anesthetize the bladder before botulinum-A toxin injections into the detrusor. Spinal Cord. 2004 Jun;42(6):338-41. doi: 10.1038/sj.sc.3101593. PMID 15007374
- Faure Walker N, Macpherson F, Tasleem A, Rampal T. Interventions to improve tolerability of local anesthetic intradetrusor Botulinum toxin injections: A systematic review. Neurourol Urodyn. 2023 Jan;42(1):23-32. doi: 10.1002/nau.25061. Epub 2022 Oct 23. PMID 36378811
- Cox L, Cameron AP. OnabotulinumtoxinA for the treatment of overactive bladder. Res Rep Urol. 2014 Jul 21;6:79-89. doi: 10.2147/RRU.S43125. eCollection 2014. PMID 25157339
Identifiers
NCT: NCT06437899 · 21346 · AUB