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Botulinum Toxin for Urinary Tract Disease: After a Decade from...
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Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval

A special issue of Toxins (ISSN 2072-6651). This special issue belongs to the section "Bacterial Toxins".

Deadline for manuscript submissions: 28 February 2025 | Viewed by 7601

Special Issue Editor

Dr. Heinrich Schulte-Baukloh

E-Mail Website
Guest Editor
Department of Urology, and Urologic Private Practice, Charité—University Hospital Berlin, Berlin, Germany
Interests: neuro-urology; urodynamics; LUTS

Special Issue Information

Dear Colleagues,

Botulinum toxin was approved by the FDA in 2011 for neurogenic bladder and in 2013 for idiopathic overactive bladder. For this Special Issue, we would like to address the question of where we stand with this therapy a decade later: has it prevailed and been proven useful? Which techniques have become established, and how were they optimized? Are there more practical ways of distribution on the way? What obstacles/acceptance problems might there be from patients or doctors in (long-term) use? What are the risks, if any? Has the therapy gained a foothold in the outpatient sector?

Dr. Heinrich Schulte-Baukloh
Guest Editor

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Keywords

  • urinary bladder
  • botulinum toxin
  • neurogenic bladder
  • incontinence
  • injection technique

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Published Papers (7 papers)

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Research

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10 pages, 777 KiB  
Article
Assessing the Use of BotulinumtoxinA for Hyperactive Urinary Tract Dysfunction a Decade After Approval: General Versus Local Anesthesia for BotulinumtoxinA Detrusor Injection
by Heinrich Schulte-Baukloh, Apostolos Apostolidis, Catarina Weiss, Thorsten Schlomm, Sarah Weinberger, Dirk Höppner, Kathrin Haberecht, Carsten Waskow, Hendrik Borgmann, Jörg Neymeyer and Bernhard Ralla
Toxins 2024, 16(11), 462; https://doi.org/10.3390/toxins16110462 - 28 Oct 2024
Viewed by 555
Abstract
Background: The onabotulinumtoxinA detrusor injection (OnabotA DI) was approved a decade ago for the treatment of patients with idiopathic overactive bladder (iOAB) or neurogenic detrusor overactivity (nDO) dysfunction who had not been treated successfully otherwise. The procedure is usually performed under local [...] Read more.
Background: The onabotulinumtoxinA detrusor injection (OnabotA DI) was approved a decade ago for the treatment of patients with idiopathic overactive bladder (iOAB) or neurogenic detrusor overactivity (nDO) dysfunction who had not been treated successfully otherwise. The procedure is usually performed under local anesthesia (LA), and various approaches have been investigated to make the procedure as painless as possible. We examined the level of anxiety and pain experienced by patients who wanted to have the procedure performed under LA or general anesthesia (GA). Material and Methods: Patients scheduled for OnabotA DI were able to choose the anesthesia procedure (LA or GA). The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was used to grade anxiety before anesthesia or before the procedure itself. Intra- and postoperative pain was determined using the Visual Analogue Scale (VAS). Various established questionnaires (including the Urinary Distress Inventory UDI-6), as well as a postoperative satisfaction questionnaire, were used to evaluate the success of the therapy. Results: In total, 104 patients (93 F, 11 M; age 64.0 (22–89) years; 80× iOAB, 24× nDO) were evaluated. OnabotA-DI was performed with LA in 72 patients and GA in 32. Stratified by first versus repeat injection in the LA group, there was a significant decrease in the Anxiety Score in the first vs. repeat injection group (p = 0.038). The LA group showed higher concerns in the anesthesia questions of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) than the GA group (OR: 0.29, 95%CI: 0.02–1.74). The VAS Pain Score during the procedure was significantly lower in the GA group compared to the LA group (LA: 3.3 ± 2.2, GA group 1.5 ± 1.5; p < 0.001). There were no differences in the success of therapy. Despite the fear and pain, patients preferred LA to GA. Conclusions: This study shows that the anxiety and pain burden of patients undergoing OnabotA-DI under LA is significant in comparison to GA during the first injection, but insignificant for following injections. Overall, LA is favored over GA. Full article
(This article belongs to the Special Issue Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval)
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11 pages, 1304 KiB  
Article
An Alternative Approach for Treating Female Underactive Bladders with Chronic Urine Retention: A Pilot Study on Combined Transvaginal Ultrasound-Guided Botulinum Toxin A External Sphincter Injection and Transurethral Incision of the Bladder Neck
by Wei-Chun Huang, Cheng-Yen Tsai and Eric Chieh-Lung Chou
Toxins 2024, 16(10), 441; https://doi.org/10.3390/toxins16100441 - 14 Oct 2024
Viewed by 745
Abstract
Background: Treating an underactive bladder (UAB) is challenging. Previously, we introduced a more precise method of transvaginal ultrasound-guided botulinum toxin A (BoNT-A) injection into the external urethral sphincter as a treatment option for patients with UABs. Although many patients experience good results, those [...] Read more.
Background: Treating an underactive bladder (UAB) is challenging. Previously, we introduced a more precise method of transvaginal ultrasound-guided botulinum toxin A (BoNT-A) injection into the external urethral sphincter as a treatment option for patients with UABs. Although many patients experience good results, those with an UAB and excessive residual urine still require catheterization. Therefore, we developed a new method that combines transvaginal ultrasound-guided BoNT-A injection with a transurethral bladder neck incision. Methods: A prospective study was conducted on 16 patients who experienced symptoms of UAB and chronic urine retention. The treatment consisted of a combination of transvaginal ultrasound-guided BoNT-A injection and a transurethral incision of the bladder neck (TUI-BN). The primary objective was to assess the efficacy of this combined treatment in improving symptoms in women with UABs. Results: Our study demonstrated significant improvements after treatment, including increased voiding volume, decreased post-void residual (PVR) urine, and improved voiding efficiency. The frequency of clean intermittent catheterization (CIC) decreased at 1 and 3 months post-surgery, along with improvements in the AUA symptoms score and the Patient Perception of Bladder Condition (PPBC) score. Conclusions: Our study showed significant improvements in the surgical treatment of UABs using a combination of transvaginal ultrasound-guided BoNT-A and TUI-BN. Full article
(This article belongs to the Special Issue Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval)
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11 pages, 410 KiB  
Article
Assessing the Use of BotulinumtoxinA for Hyperactive Urinary Tract Dysfunction a Decade after Approval: A Single-Blind Study to Evaluate the Reduction in Pain in OnabotulinumtoxinA Detrusor Injection Using Different Injection Needles
by Heinrich Schulte-Baukloh, Catarina Weiss, Thorsten Schlomm, Sarah Weinberger, Hendrik Borgmann, Dirk Höppner, Kathrin Haberecht and Jörg Neymeyer
Toxins 2024, 16(9), 395; https://doi.org/10.3390/toxins16090395 - 14 Sep 2024
Viewed by 624
Abstract
Overactive bladder (OAB) has a significant impact on the quality of life; thus, it requires treatment that can be adhered to over a long period without undue side effects. The current treatment which uses an anticholinergic or β-3 agonist may fail to improve [...] Read more.
Overactive bladder (OAB) has a significant impact on the quality of life; thus, it requires treatment that can be adhered to over a long period without undue side effects. The current treatment which uses an anticholinergic or β-3 agonist may fail to improve symptoms and has side effects, leading to high discontinuation rates. OnabotulinumtoxinA (OnabotA) detrusor injection has been approved for idiopathic OAB as a second-line treatment with good effectiveness and tolerability. This study used a visual analog scale (VAS) to assess the impact of the type of needle used for OnabotA detrusor injections under local anesthesia on the pain levels after each injection. This study included 68 female patients. We used three different needles with thicknesses ranging from 22 to 27 gauge, lengths between 4 and 5 mm, and different cuts. The sensation of pain was rated at each standardized injection location. Regardless of the needle used, the patients’ perceptions of pain at the beginning of the procedure were rated as being less than the subsequent injections. Most pain sensations were rated as low to moderate. The mean pain sensation on the VAS was 2.5 ± 0.3 overall, i.e., for all patients and needles used. Statistically significant differences in pain sensation were rated only at some locations of the bladder (on the back wall and the right side of the bladder). The single needles averaged the following pain scores: 2.8 ± 0.3 for needle A (20 G, 4 mm), 2.1 ± 0.3 for needle B (27 G, 5 mm), and 2.6 ± 0.4 for needle C (20 G, 4 mm, sharp cut 15°). The 27-gauge needle caused significantly less pain, and it had no negative impact due to its length, which was 1 mm longer than the other needles. Thus, the needle thickness was a decisive factor in the patients’ perceptions of pain. Full article
(This article belongs to the Special Issue Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval)
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9 pages, 270 KiB  
Article
Efficacy, Satisfaction, and Compliance: Insights from 15 Years of Botulinum Toxin Use for Female Urgency Urinary Incontinence
by Margarida Manso, João Diogo Soares, Margarida Henriques, Francisco Botelho, Carlos Silva and Francisco Cruz
Toxins 2024, 16(8), 332; https://doi.org/10.3390/toxins16080332 - 26 Jul 2024
Viewed by 772
Abstract
Urgency urinary incontinence (UUI) refractory to medical treatment poses significant challenges despite advancements. This study evaluates the efficacy of intravesical botulinum toxin for UUI and identifies factors influencing treatment outcomes. Among 368 women receiving botulinum toxin injections, 74.5% achieved a complete discontinuation of [...] Read more.
Urgency urinary incontinence (UUI) refractory to medical treatment poses significant challenges despite advancements. This study evaluates the efficacy of intravesical botulinum toxin for UUI and identifies factors influencing treatment outcomes. Among 368 women receiving botulinum toxin injections, 74.5% achieved a complete discontinuation of pad usage. Predictors of efficacy included lower pre-treatment pad usage and the absence of prior sling placement. Patients often required repeat injections (60.3%), with younger age and satisfaction correlating with treatment repetition. The interval between injections averaged 18 months, influenced by logistical challenges and patient preferences. Despite concerns about diminishing efficacy, subjective perceptions did not align with objective findings. Limitations include retrospective analysis and heterogeneous clinical records. In conclusion, intravesical botulinum toxin is effective for UUI, with pre-treatment pad usage and sling placement history influencing outcomes and patient characteristics influencing treatment repetition. Full article
(This article belongs to the Special Issue Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval)
21 pages, 4815 KiB  
Article
A Novel Catalytically Inactive Construct of Botulinum Neurotoxin A (BoNT/A) Directly Inhibits Visceral Sensory Signalling
by Hodan Ibrahim, Kevin Retailleau, Fraser Hornby, Jacquie Maignel, Matthew Beard and Donna Marie Daly
Toxins 2024, 16(1), 30; https://doi.org/10.3390/toxins16010030 - 7 Jan 2024
Cited by 1 | Viewed by 2102
Abstract
Botulinum neurotoxin A (BoNT/A) is a potent neurotoxin that silences cholinergic neurotransmission through the cleavage of the synaptic protein SNAP-25. Previous studies have shown that, in addition to its paralytic effects, BoNT/A can inhibit sensory nerve activity. The aim of this study was [...] Read more.
Botulinum neurotoxin A (BoNT/A) is a potent neurotoxin that silences cholinergic neurotransmission through the cleavage of the synaptic protein SNAP-25. Previous studies have shown that, in addition to its paralytic effects, BoNT/A can inhibit sensory nerve activity. The aim of this study was to identify how BoNT/A inhibits afferent signalling from the bladder. To investigate the role of SNAP-25 cleavage in the previously reported BoNT/A-dependent inhibition of sensory signalling, we developed a recombinant form of BoNT/A with an inactive light chain, rBoNT/A (0), unable to paralyse muscle. We also developed recombinant light chain (LC)-domain-only proteins to better understand the entry mechanisms, as the heavy chain (HC) of the protein is responsible for the internalisation of the light chain. We found that, despite a lack of catalytic activity, rBoNT/A (0) potently inhibited the afferent responses to bladder distension to a greater degree than catalytically active rBoNT/A. This was also clear from the testing of the LC-only proteins, as the inactive rLC/A (0) protein inhibited afferent responses significantly more than the active rLC/A protein. Immunohistochemistry for cleaved SNAP-25 was negative, and purinergic and nitrergic antagonists partially and totally reversed the sensory inhibition, respectively. These data suggest that the BoNT/A inhibition of sensory nerve activity in this assay is not due to the classical well-characterised ‘double-receptor’ mechanism of BoNT/A, is independent of SNAP25 cleavage and involves nitrergic and purinergic signalling mechanisms. Full article
(This article belongs to the Special Issue Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval)
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Review

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8 pages, 2121 KiB  
Review
Strategies for Safe Transurethral Injections of Botulinum Toxin into the Bladder Wall
by Matthias Oelke
Toxins 2024, 16(7), 299; https://doi.org/10.3390/toxins16070299 - 30 Jun 2024
Viewed by 1030
Abstract
Introduction: Transurethral injections into the bladder wall with botulinum toxin are an established treatment for refractory overactive bladder or detrusor overactivity. With the current injection technique, an average of approx. 18% and up to 40% of botulinum toxin is injected next to the [...] Read more.
Introduction: Transurethral injections into the bladder wall with botulinum toxin are an established treatment for refractory overactive bladder or detrusor overactivity. With the current injection technique, an average of approx. 18% and up to 40% of botulinum toxin is injected next to the bladder wall, potentially causing reduced efficacy or non-response. The article aims to evaluate the reasons for incorrect injections and propose strategies for complete delivery of the entire botulinum toxin fluid into the bladder wall. Material and Methods: Unstructured literature search and narrative review of the literature. Results: Incorrect injection of botulinum toxin fluid next to the bladder wall is caused by pushing the injection needle too deep and through the bladder wall. Bladder wall thickness decreases with increasing bladder filling and has a thickness of less than 2 mm beyond 100 mL in healthy individuals. Ultrasound imaging of the bladder wall before botulinum toxin injection can verify bladder wall thickness in individual patients. Patient movements during the injection therapy increase the chance of incorrect placement of the needle tip. Conclusions: Based on the literature search, it is helpful and recommended to (1) perform pretreatment ultrasound imaging of the bladder to estimate bladder wall thickness and to adjust the injection depth accordingly, (2) fill the bladder as low as possible, ideally below 100 mL, (3) use short needles, ideally 2 mm, and (4) provide sufficient anesthesia and pain management to avoid patient movements during the injection therapy. Full article
(This article belongs to the Special Issue Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval)
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Other

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21 pages, 2865 KiB  
Systematic Review
Adverse Effects of Intravesical OnabotulinumtoxinA Injection in Patients with Idiopathic Overactive Bladder or Neurogenic Detrusor Overactivity: A Systematic Review and Meta-Analysis of Randomized Controlled Studies
by Ping-Hsuan Yu and Chung-Cheng Wang
Toxins 2024, 16(8), 343; https://doi.org/10.3390/toxins16080343 - 5 Aug 2024
Cited by 2 | Viewed by 1125
Abstract
Despite the efficacy of onabotulinumtoxinA, its safety profile remains a concern. This meta-analysis reviewed the major adverse events (AEs) associated with intravesical onabotulinumtoxinA treatment in patients with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (iOAB). Randomized controlled trials (RCTs) conducted between January [...] Read more.
Despite the efficacy of onabotulinumtoxinA, its safety profile remains a concern. This meta-analysis reviewed the major adverse events (AEs) associated with intravesical onabotulinumtoxinA treatment in patients with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (iOAB). Randomized controlled trials (RCTs) conducted between January 2000 and December 2022 were searched for adult patients administered different onabotulinumtoxinA dosages or onabotulinumtoxinA vs. placebo. Quality assessment was performed using the Cochrane Collaboration tool, and statistical analysis was performed using Review Manager version 5.3. A total of 26 RCTs were included in the analysis, including 8 on NDO and 18 on iOAB. OnabotulinumtoxinA vs. placebo significantly increased the urinary tract infection (UTI) incidence in patients with NDO (relative risk, or RR, 1.54) and iOAB (RR, 2.53). No difference in the RR with different onabotulinumtoxinA dosages was noted. Urinary retention was frequent with onabotulinumtoxinA use in the NDO (RR, 6.56) and iOAB (RR, 7.32) groups. Similar observations were made regarding the risks of de novo clean intermittent catheterization (CIC). The risk of voiding difficulty increased with onabotulinumtoxinA use in patients with iOAB. Systemic AEs of onabotulinumtoxinA, including muscle weakness (RR, 2.79) and nausea (RR, 3.15), were noted in patients with NDO; most systemic AEs had a low incidence and were sporadic. Full article
(This article belongs to the Special Issue Botulinum Toxin for Urinary Tract Disease: After a Decade from Approval)
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