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 in | European urology Vol. 79; no. 4; pp. 492 - 504 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Switzerland
Elsevier B.V
01.04.2021
Elsevier |
Subjects | |
Online Access | Get full text |
ISSN | 0302-2838 1873-7560 1873-7560 1421-993X |
DOI | 10.1016/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. |
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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 |
Author_xml | – sequence: 1 givenname: Cosimo surname: De Nunzio fullname: De Nunzio, Cosimo email: cosimodenunzio@virgilio.it organization: Urology Unit, Ospedale Sant’Andrea, Sapienza University of Rome, Rome, Italy – sequence: 2 givenname: Benjamin surname: Brucker fullname: Brucker, Benjamin organization: New York University Langone Health, New York, NY, USA – sequence: 3 givenname: Thomas surname: Bschleipfer fullname: Bschleipfer, Thomas organization: Clinic for Urology, Andrology and Pediatric Urology, Clinics of Nordoberpfalz AG, Weiden, Germany – sequence: 4 givenname: Jean-Nicolas surname: Cornu fullname: Cornu, Jean-Nicolas organization: Urology Department, Charles Nicolle University Hospital, University of Rouen F-76000, Rouen, France – sequence: 5 givenname: Marcus J. surname: Drake fullname: Drake, Marcus J. organization: Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK – sequence: 6 givenname: Ferdinando surname: Fusco fullname: Fusco, Ferdinando organization: Urology Unit, University of Campania L. Vanvitelli, Naples, Italy – sequence: 7 givenname: Stavros surname: Gravas 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 – sequence: 11 givenname: Gommert 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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Keywords | Antimuscarinics Overactive bladder Lower urinary tract symptoms Men |
Language | English |
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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 |
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