Beyond Antimuscarinics: A Review of Pharmacological and Interventional Options for Overactive Bladder Management in Men

The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce. The aim of this syste...

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Published inEuropean urology Vol. 79; no. 4; pp. 492 - 504
Main Authors De Nunzio, Cosimo, Brucker, Benjamin, Bschleipfer, Thomas, Cornu, Jean-Nicolas, Drake, Marcus J., Fusco, Ferdinando, Gravas, Stavros, Oelke, Matthias, Peyronnet, Benoit, Tutolo, Manuela, van Koeveringe, Gommert, Madersbacher, Stephan
Format Journal Article
LanguageEnglish
Published Switzerland Elsevier B.V 01.04.2021
Elsevier
Subjects
Online AccessGet full text
ISSN0302-2838
1873-7560
1873-7560
1421-993X
DOI10.1016/j.eururo.2020.12.032

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Abstract The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce. The aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB. A search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: “male/man,” “LUTS,” “overactive bladder,” “storage symptoms,” “urgency,” “nocturia,” “incontinence,” “beta-3 agonist,” “PDE-5 inhibitors,” “botulinum toxin,” “sacral nerve stimulation/neurostimulation,” “percutaneous/transcutaneous tibial nerve stimulation,” “PTENS,” and “combination therapy.” Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223. Overall, 24 studies were retrieved. In male OAB, mirabegron (MIRA) is the most intensively investigated pharmacological option. A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (–0.37, 95% confidence interval [CI]: –0.74, –0.01, p <  0.05). A pooled analysis of three RCTs, including 1317 male patients, has also shown that the addition of MIRA 50 mg in men receiving the α1-blocker tamsulosin improved the mean number of micturitions per day (–0.27, 95% CI: –0.46 to –0.09, p <  0.05), urgency episodes (–0.50, 95% CI: –0.77 to –0.22, p <  0.05), total OAB symptom score (–0.66, 95% CI: –1.00 to –0.38, p <  0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87–16.64, p <  0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5–42%) is observed in male than in female patients. Data on nerve stimulation are scarce. MIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients’ characteristics. Overactive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined. Literature on pharmacological treatment of male patients with overactive bladder is scarce. Most of the available evidence is on mirabegron, which is effective and well tolerated. Phosphodiesterase-5 inhibitors, botulinum toxin A, and neuromodulation are still to be considered investigational treatments.
AbstractList The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce. The aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB. A search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: "male/man," "LUTS," "overactive bladder," "storage symptoms," "urgency," "nocturia," "incontinence," "beta-3 agonist," "PDE-5 inhibitors," "botulinum toxin," "sacral nerve stimulation/neurostimulation," "percutaneous/transcutaneous tibial nerve stimulation," "PTENS," and "combination therapy." Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223. Overall, 24 studies were retrieved. In male OAB, mirabegron (MIRA) is the most intensively investigated pharmacological option. A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (-0.37, 95% confidence interval [CI]: -0.74, -0.01, p <  0.05). A pooled analysis of three RCTs, including 1317 male patients, has also shown that the addition of MIRA 50 mg in men receiving the α -blocker tamsulosin improved the mean number of micturitions per day (-0.27, 95% CI: -0.46 to -0.09, p <  0.05), urgency episodes (-0.50, 95% CI: -0.77 to -0.22, p <  0.05), total OAB symptom score (-0.66, 95% CI: -1.00 to -0.38, p <  0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87-16.64, p <  0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5-42%) is observed in male than in female patients. Data on nerve stimulation are scarce. MIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients' characteristics. Overactive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined.
The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce. The aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB. A search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: “male/man,” “LUTS,” “overactive bladder,” “storage symptoms,” “urgency,” “nocturia,” “incontinence,” “beta-3 agonist,” “PDE-5 inhibitors,” “botulinum toxin,” “sacral nerve stimulation/neurostimulation,” “percutaneous/transcutaneous tibial nerve stimulation,” “PTENS,” and “combination therapy.” Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223. Overall, 24 studies were retrieved. In male OAB, mirabegron (MIRA) is the most intensively investigated pharmacological option. A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (–0.37, 95% confidence interval [CI]: –0.74, –0.01, p <  0.05). A pooled analysis of three RCTs, including 1317 male patients, has also shown that the addition of MIRA 50 mg in men receiving the α1-blocker tamsulosin improved the mean number of micturitions per day (–0.27, 95% CI: –0.46 to –0.09, p <  0.05), urgency episodes (–0.50, 95% CI: –0.77 to –0.22, p <  0.05), total OAB symptom score (–0.66, 95% CI: –1.00 to –0.38, p <  0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87–16.64, p <  0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5–42%) is observed in male than in female patients. Data on nerve stimulation are scarce. MIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients’ characteristics. Overactive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined. Literature on pharmacological treatment of male patients with overactive bladder is scarce. Most of the available evidence is on mirabegron, which is effective and well tolerated. Phosphodiesterase-5 inhibitors, botulinum toxin A, and neuromodulation are still to be considered investigational treatments.
The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce.CONTEXTThe role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce.The aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB.OBJECTIVEThe aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB.A search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: "male/man," "LUTS," "overactive bladder," "storage symptoms," "urgency," "nocturia," "incontinence," "beta-3 agonist," "PDE-5 inhibitors," "botulinum toxin," "sacral nerve stimulation/neurostimulation," "percutaneous/transcutaneous tibial nerve stimulation," "PTENS," and "combination therapy." Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223.EVIDENCE ACQUISITIONA search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: "male/man," "LUTS," "overactive bladder," "storage symptoms," "urgency," "nocturia," "incontinence," "beta-3 agonist," "PDE-5 inhibitors," "botulinum toxin," "sacral nerve stimulation/neurostimulation," "percutaneous/transcutaneous tibial nerve stimulation," "PTENS," and "combination therapy." Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223.Overall, 24 studies were retrieved. In male OAB, mirabegron (MIRA) is the most intensively investigated pharmacological option. A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (-0.37, 95% confidence interval [CI]: -0.74, -0.01, p <  0.05). A pooled analysis of three RCTs, including 1317 male patients, has also shown that the addition of MIRA 50 mg in men receiving the α1-blocker tamsulosin improved the mean number of micturitions per day (-0.27, 95% CI: -0.46 to -0.09, p <  0.05), urgency episodes (-0.50, 95% CI: -0.77 to -0.22, p <  0.05), total OAB symptom score (-0.66, 95% CI: -1.00 to -0.38, p <  0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87-16.64, p <  0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5-42%) is observed in male than in female patients. Data on nerve stimulation are scarce.EVIDENCE SYNTHESISOverall, 24 studies were retrieved. In male OAB, mirabegron (MIRA) is the most intensively investigated pharmacological option. A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (-0.37, 95% confidence interval [CI]: -0.74, -0.01, p <  0.05). A pooled analysis of three RCTs, including 1317 male patients, has also shown that the addition of MIRA 50 mg in men receiving the α1-blocker tamsulosin improved the mean number of micturitions per day (-0.27, 95% CI: -0.46 to -0.09, p <  0.05), urgency episodes (-0.50, 95% CI: -0.77 to -0.22, p <  0.05), total OAB symptom score (-0.66, 95% CI: -1.00 to -0.38, p <  0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87-16.64, p <  0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5-42%) is observed in male than in female patients. Data on nerve stimulation are scarce.MIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients' characteristics.CONCLUSIONSMIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients' characteristics.Overactive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined.PATIENT SUMMARYOveractive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined.
Author Fusco, Ferdinando
Cornu, Jean-Nicolas
Gravas, Stavros
Madersbacher, Stephan
Tutolo, Manuela
Bschleipfer, Thomas
Drake, Marcus J.
van Koeveringe, Gommert
Brucker, Benjamin
Oelke, Matthias
De Nunzio, Cosimo
Peyronnet, Benoit
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  givenname: Cosimo
  surname: De Nunzio
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  organization: Urology Unit, Ospedale Sant’Andrea, Sapienza University of Rome, Rome, Italy
– sequence: 2
  givenname: Benjamin
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  fullname: Brucker, Benjamin
  organization: New York University Langone Health, New York, NY, USA
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  givenname: Thomas
  surname: Bschleipfer
  fullname: Bschleipfer, Thomas
  organization: Clinic for Urology, Andrology and Pediatric Urology, Clinics of Nordoberpfalz AG, Weiden, Germany
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  givenname: Jean-Nicolas
  surname: Cornu
  fullname: Cornu, Jean-Nicolas
  organization: Urology Department, Charles Nicolle University Hospital, University of Rouen F-76000, Rouen, France
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  givenname: Marcus J.
  surname: Drake
  fullname: Drake, Marcus J.
  organization: Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
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  fullname: Fusco, Ferdinando
  organization: Urology Unit, University of Campania L. Vanvitelli, Naples, Italy
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  givenname: Stavros
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  fullname: Gravas, Stavros
  organization: Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
– sequence: 8
  givenname: Matthias
  surname: Oelke
  fullname: Oelke, Matthias
  organization: Department of Urology, Pediatric Urology & Urological Oncology, St. Antonius Hospital, Gronau, Germany
– sequence: 9
  givenname: Benoit
  surname: Peyronnet
  fullname: Peyronnet, Benoit
  organization: Department of Urology, University of Rennes, Rennes, France
– sequence: 10
  givenname: Manuela
  surname: Tutolo
  fullname: Tutolo, Manuela
  organization: Division of Oncology, Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy
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  surname: van Koeveringe
  fullname: van Koeveringe, Gommert
  organization: Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands
– sequence: 12
  givenname: Stephan
  surname: Madersbacher
  fullname: Madersbacher, Stephan
  organization: Department of Urology, Clinic Favoriten and Sigmund Freud Private University, Vienna, Austria
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ContentType Journal Article
Copyright 2020 European Association of Urology
Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Distributed under a Creative Commons Attribution 4.0 International License
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Fri Feb 23 02:39:34 EST 2024
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IsPeerReviewed true
IsScholarly true
Issue 4
Keywords Antimuscarinics
Overactive bladder
Lower urinary tract symptoms
Men
Language English
License Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Distributed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0
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Snippet The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and...
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SubjectTerms Acetanilides - adverse effects
Antimuscarinics
Botulinum Toxins, Type A - therapeutic use
Female
Human health and pathology
Humans
Life Sciences
Lower urinary tract symptoms
Male
Men
Muscarinic Antagonists - adverse effects
Overactive bladder
Phosphodiesterase 5 Inhibitors
Tamsulosin
Treatment Outcome
Urinary Bladder, Overactive - diagnosis
Urinary Bladder, Overactive - drug therapy
Urology and Nephrology
Title Beyond Antimuscarinics: A Review of Pharmacological and Interventional Options for Overactive Bladder Management in Men
URI https://www.clinicalkey.com/#!/content/1-s2.0-S0302283820310186
https://dx.doi.org/10.1016/j.eururo.2020.12.032
https://www.ncbi.nlm.nih.gov/pubmed/33402296
https://www.proquest.com/docview/2475531408
https://normandie-univ.hal.science/hal-03163883
Volume 79
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