Delivery of intravesical botulinum toxin A using low-energy shockwaves in the treatment of overactive bladder: A preliminary clinical study

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ABSTRACT

Objective: To evaluate the efficacy and safety of botulinum toxin A (BoNT-A) instillation in the bladder under the effect of low-energy shockwaves (LESWs) for the treatment of refractory idiopathic overactive bladder (OAB).

Patients and methods: A preliminary clinical study was conducted, including 15 patients with refractory OAB, between September 2016 and July 2017. Intravesical instillation of 100 IU of BoNT-A was done followed by LESWs (3000 shocks over 10 min) exposure to the supra-pubic area. Patients were followed-up by urine analysis, urine culture, post-void residual urine volume (PVR), and Overactive Bladder Symptom Score (OABSS) at 1, 2 and 3 months.

Results: There were statistically significant improvements in all OABSS domains and the total score after 1 and 2 months of treatment ( P < 0.05). Whereas, only the nocturia domain remained significantly improved after 3 months ( P = 0.02). There was no significant increase in PVR throughout the study period ( P > 0.05) and none of the patients required clean intermittent catheterisation. Two, two and three patients developed urinary tract infections after 1, 2 and 3 months, respectively.

Conclusion: Intravesical instillation of BoNT-A and LESWs is safe and effective method for the treatment of refractory OAB with a durable response for 2 months.

Abbreviations: BoNT-A: botulinum toxin A; CIC: clean intermittent catheterisation; DO: detrusor overactivity; LESWs: low-energy shockwaves; OAB: overactive bladder; OABSS: Overactive Bladder Symptom Score; Q _max: maximum urinary flow rate; QoL: quality of life; UUI: urgency urinary incontinence

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Most cited references 15

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Symptom assessment tool for overactive bladder syndrome--overactive bladder symptom score.

Masayuki Takeda, Hidehiro Kakizaki, Osamu Yamaguchi … (2006)

Overactive bladder (OAB) is a common symptom syndrome with urgency, urinary frequency, and urgency incontinence. To collectively express OAB symptoms, we developed the overactive bladder symptom score (OABSS). Four symptoms--daytime frequency, nighttime frequency, urgency, and urgency incontinence--were scored. The weighing score was based on a secondary analysis of an epidemiologic database. Psychometric properties were examined in five patient groups: OAB (n = 83), asymptomatic controls (n = 34), stress incontinence (n = 29), benign prostatic hyperplasia (n = 28), and other diseases with urinary symptoms (n = 26). The maximal score was defined as 2, 3, 5, and 5 for daytime frequency, nighttime frequency, urgency, and urgency incontinence, respectively. The sum score (OABSS 0 to 15) was significantly greater in the patients with OAB (8.36) than in the other patient groups (1.82 to 5.14). The distribution of the OABSS showed a clear separation between those with OAB and asymptomatic controls. The OABSS correlated positively with the individual scores (Spearman's r = 0.10 to 0.78) and quality-of-life scores assessed by the King's Health Questionnaire (Spearman's r = 0.20 to 0.49). The weighted kappa coefficients were 0.804 to 1.0 for each symptom score and 0.861 for OABSS. The posttreatment reduction in the OABSS was consistent with the global impression of patients of the therapeutic efficacy. The OABSS, the sum score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence), has been developed and validated. OABSS may be a useful tool for research and clinical practice.

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OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial.

Christopher Chapple, Karl-Dietrich Sievert, Scott MacDiarmid … (2013)

Overactive bladder (OAB) syndrome with urinary incontinence (UI) is prevalent in the population and impairs health-related quality of life (HRQOL). To assess the impact on efficacy, safety, and HRQOL of onabotulinumtoxinA (BOTOX(®), Allergan, Inc.) treatment in patients with OAB with UI. This pivotal, multicentre, double-blind, randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic OAB with ≥ 3 urgency UI episodes over 3 d and ≥ 8 micturitions per day who were inadequately managed by anticholinergics. OnabotulinumtoxinA at a 100U dose (n=277) or placebo (n=271), administered as 20 intradetrusor injections of 0.5 ml. Co-primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale (TBS) at week 12. Additional end points included other OAB symptoms (episodes of urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety assessments included adverse events (AEs), postvoid residual (PVR) urine volume, and initiation of clean intermittent catheterisation (CIC). OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (-2.95 for onabotulinumtoxinA versus -1.03 for placebo; p<0.001). Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo (p ≤ 0.01). Patients perceived a significant improvement in their condition, as measured by patients with a positive treatment response on the TBS (62.8% for onabotulinumtoxinA versus 26.8% for placebo; p<0.001). Clinically meaningful improvements from baseline in all I-QOL and KHQ multi-item domains (p<0.001 versus placebo) indicated positive impact on HRQOL. AEs were mainly localised to the urinary tract. Mean PVR was higher in the onabotulinumtoxinA group (46.9 ml versus 10.1 ml at week 2; p<0.001); 6.9% of onabotulinumtoxinA patients versus 0.7% of placebo patients initiated CIC. OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinically relevant improvements in all OAB symptoms, patient-reported benefit, and HRQOL in patients inadequately managed by anticholinergics. ClinicalTrials.gov: NCT00910520. Copyright © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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Refractory idiopathic urge urinary incontinence and botulinum A injection.

Linda Brubaker, Holly Richter, Anthony Visco … (2008)

We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence. This institutional review board approved, multicenter registered trial randomized women with refractory urge incontinence, detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio. Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence. The primary outcome measure was time to failure, as evidenced by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection, or changes in treatment (initiation or increase) at any time after injection. Safety data, including increased post-void residual volume, defined as more than 200 ml irrespective of symptoms, was obtained at specified time points. Approximately 60% of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement. The median duration of their responses was 373 days, significantly longer than the 62 days or less for placebo (p <0.0001). In the botulinum toxin A group increased post-void residual urine (12 of 28 women or 43%) and urinary tract infection in those with increased post-void residual urine (9 of 12 or 75%) exceeded expected ranges. Further injections were stopped after 43 patients were randomized, including 28 to botulinum toxin A and 15 to placebo. Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder. However, a transient post-void residual urine increase was experienced in 43% of patients. Botulinum toxin A for idiopathic overactive bladder is still under investigation.

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Author and article information

Journal

Journal ID (nlm-ta): Arab J Urol

Journal ID (publisher-id): TAJU

Journal ID (publisher-id): taju20

Title: Arab Journal of Urology

Publisher: Taylor & Francis

ISSN (Print): 2090-598X

ISSN (Electronic): 2090-5998

Publication date Collection: 2019

Publication date (Electronic): 15 May 2019

Volume: 17

Issue: 3

Pages: 216-220

Affiliations

Urology and Nephrology Center, Mansoura University , Mansoura, Egypt

Author notes

CONTACT Mohamed H. Zahran zahranmha822@ 123456gmail.com ; zahranmha@ 123456mans.edu.eg Urology and Nephrology Center, Mansoura University , Mansoura, Egypt

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Mohamed H. Zahran http://orcid.org/0000-0002-2897-1023

Article

Publisher ID: 1605676

DOI: 10.1080/2090598X.2019.1605676

PMC ID: 6711027

PubMed ID: 31489238

SO-VID: cd60a3be-f9ed-4baa-87c2-ec616280dd59

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 23 December 2018

Date accepted : 25 March 2019

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Figures: 1, Tables: 4, References: 20, Pages: 5

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Delivery of intravesical botulinum toxin A using low-energy shockwaves in the treatment of overactive bladder: A preliminary clinical study

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Most cited references 15

Symptom assessment tool for overactive bladder syndrome--overactive bladder symptom score.

OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial.

Refractory idiopathic urge urinary incontinence and botulinum A injection.

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