Safety and Efficacy of Trospium Chloride and Solifenacin in Stroke-Induced Neurogenic Lower Urinary Tract Dysfunction: A Randomized Controlled Trial.
Solifenacin
Trospium chloride
neurogenic lower urinary tract symptoms
neurogenic urinary bladder
stroke
Journal
Neurourology and urodynamics
ISSN: 1520-6777
Titre abrégé: Neurourol Urodyn
Pays: United States
ID NLM: 8303326
Informations de publication
Date de publication:
29 Oct 2024
29 Oct 2024
Historique:
revised:
24
09
2024
received:
14
05
2024
accepted:
14
10
2024
medline:
29
10
2024
pubmed:
29
10
2024
entrez:
29
10
2024
Statut:
aheadofprint
Résumé
Neurogenic dysfunction of the lower urinary tract is one of the challenging diseases with high burdens in urology. Our study aims to evaluate the efficacy of a 4-week treatment with Solifenacin and Trospium chloride and assess their safety and impact on quality of life. Following the selection of 206 stroke patients from two centers who met specific eligibility criteria, including a clinical diagnosis of stroke, normal cognitive function, and the presence of lower urinary tract symptoms (LUTS), participants were randomly assigned to receive oral Solifenacin, Trospium chloride, or a placebo. Under the supervision of the Ethics Committee, the baseline characteristics, compliance with medication, and outcomes were monitored, gathered, and analyzed. The majority of participants were male, with a mean age of 67.3, and most had ischemic stroke. The groups had no significant difference in urinary symptoms after stroke. All of the symptoms in the study groups, according to the NBSS questionnaire, were decreased following treatment compared to the baseline (p < 0.05). After treatment, ICIQ-OAB, and ICIQ-LUTS-QOL total scores and bothersome scores decreased significantly compared to baseline (p < 0.001). When compared to the placebo, both Trospium chloride and Solifenacin alleviated symptoms according to the NBSS questionnaire and ICIQ-LUTS-QOL, total ICIQ-OAB, and the total score of ICIQ-OAB-Bothersome. However, the total LUTS-QOL-Bothersome score did not change in the active treatment groups compared to the placebo. While comparing the two drugs, these values were similar except for the total score of LUTS-QOL-Bothersome, ICIQ-OAB, and ICIQ-OAB-Bothersome in favor of the Solifenacin group. Moreover, Solifenacin had fewer side effects compared to Trospium chloride or placebo. The study analyzed 206 stroke patients in two international centers and found both drug arms effective in treating overactive bladder. However, inconsistencies were found in efficacy and safety, necessitating further studies with larger populations. This triple-blind, multicenter, randomized controlled trial was done on 206 stroke patients after getting Ethical Committee approval and registering the project on IRCT (IRCT20160606028304N2).
Sections du résumé
BACKGROUND
BACKGROUND
Neurogenic dysfunction of the lower urinary tract is one of the challenging diseases with high burdens in urology. Our study aims to evaluate the efficacy of a 4-week treatment with Solifenacin and Trospium chloride and assess their safety and impact on quality of life.
METHODS
METHODS
Following the selection of 206 stroke patients from two centers who met specific eligibility criteria, including a clinical diagnosis of stroke, normal cognitive function, and the presence of lower urinary tract symptoms (LUTS), participants were randomly assigned to receive oral Solifenacin, Trospium chloride, or a placebo. Under the supervision of the Ethics Committee, the baseline characteristics, compliance with medication, and outcomes were monitored, gathered, and analyzed.
RESULTS
RESULTS
The majority of participants were male, with a mean age of 67.3, and most had ischemic stroke. The groups had no significant difference in urinary symptoms after stroke. All of the symptoms in the study groups, according to the NBSS questionnaire, were decreased following treatment compared to the baseline (p < 0.05). After treatment, ICIQ-OAB, and ICIQ-LUTS-QOL total scores and bothersome scores decreased significantly compared to baseline (p < 0.001). When compared to the placebo, both Trospium chloride and Solifenacin alleviated symptoms according to the NBSS questionnaire and ICIQ-LUTS-QOL, total ICIQ-OAB, and the total score of ICIQ-OAB-Bothersome. However, the total LUTS-QOL-Bothersome score did not change in the active treatment groups compared to the placebo. While comparing the two drugs, these values were similar except for the total score of LUTS-QOL-Bothersome, ICIQ-OAB, and ICIQ-OAB-Bothersome in favor of the Solifenacin group. Moreover, Solifenacin had fewer side effects compared to Trospium chloride or placebo.
CONCLUSION
CONCLUSIONS
The study analyzed 206 stroke patients in two international centers and found both drug arms effective in treating overactive bladder. However, inconsistencies were found in efficacy and safety, necessitating further studies with larger populations.
TRIAL REGISTRATION
BACKGROUND
This triple-blind, multicenter, randomized controlled trial was done on 206 stroke patients after getting Ethical Committee approval and registering the project on IRCT (IRCT20160606028304N2).
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : This study is supported by the research vice chancellor of Tabriz University of Medical Sciences (Grant No. 63865).
Informations de copyright
© 2024 Wiley Periodicals LLC.
Références
R. Sakakibara, “Lower Urinary Tract Dysfunction in Patients With Brain Lesions,” Handbook of Clinical Neurology 130 (2015): 269–287.
S. Tibaek, G. Gard, P. Klarskov, H. K. Iversen, C. Dehlendorff, and R. Jensen, “Prevalence of Lower Urinary Tract Symptoms (LUTS) in Stroke Patients: A Cross‐Sectional, Clinical Survey,” Neurourology and Urodynamics 27 (2008): 763–771, https://doi.org/10.1002/nau.20605.
M. P. Williams, V. Srikanth, M. Bird, and A. G. Thrift, “Urinary Symptoms and Natural History of Urinary Continence After First‐Ever Stroke—A Longitudinal Population‐Based Study,” Age and Ageing 41 (2012): 371–376, https://doi.org/10.1093/ageing/afs009.
M. Stöhrer, B. Blok, D. Castro‐Diaz, et al., “EAU Guidelines on Neurogenic Lower Urinary Tract Dysfunction,” European Urology 56 (2009): 81–88, https://doi.org/10.1016/j.eururo.2009.04.028.
D. R. Guay, “Trospium Chloride: An Update on a Quaternary Anticholinergic for Treatment of Urge Urinary Incontinence,” Therapeutics and Clinical Risk Management 1 (2005): 157–166, https://doi.org/10.2147/tcrm.1.2.157.62912.
P. Herbison, “Effectiveness of Anticholinergic Drugs Compared With Placebo in the Treatment of Overactive Bladder: Systematic Review,” BMJ 326 (2003): 841–844, https://doi.org/10.1136/bmj.326.7394.841.
R. Basra and C. Kelleher, “A Review of Solifenacin in the Treatment of Urinary Incontinence,” Therapeutics and Clinical Risk Management 4 (2008): 117–128, https://doi.org/10.2147/tcrm.s1274.
H. Mostafaei, H. Salehi‐Pourmehr, S. Jilch, et al., “Choosing the Most Efficacious and Safe Oral Treatment for Idiopathic Overactive Bladder: A Systematic Review and Network Meta‐Analysis,” European Urology Focus 8 (2022): 1072–1089, https://doi.org/10.1016/j.euf.2021.08.011.
G. G. Kay, M. B. Abou‐Donia, W. S. Messer, Jr., D. G. Murphy, J. W. Tsao, and J. G. Ouslander, “Antimuscarinic Drugs for Overactive Bladder and Their Potential Effects on Cognitive Function in Older Patients,” Journal of the American Geriatrics Society 53 (2005): 2195–2201, https://doi.org/10.1111/j.1532-5415.2005.00537.x.
H. Madersbacher, M. Stöhrer, R. Richter, H. Burgdörfer, H. J. Hachen, and G. Mürtz, “Trospium Chloride Versus Oxybutynin: A Randomized, Double‐Blind, Multicentre Trial in the Treatment of Detrusor Hyper‐Reflexia,” British Journal of Urology 75 (1995): 452–456, https://doi.org/10.1111/j.1464-410x.1995.tb07264.x.
M. Chancellor and T. Boone, “Anticholinergics for Overactive Bladder Therapy: Central Nervous System Effects,” CNS Neuroscience & Therapeutics 18 (2012): 167–174, https://doi.org/10.1111/j.1755-5949.2011.00248.x.
E. S. Rovner, “Trospium Chloride in the Management of Overactive Bladder,” Drugs 64 (2004): 2433–2446, https://doi.org/10.2165/00003495-200464210-00005.
W. S. Reynolds, M. McPheeters, J. Blume, et al., “Comparative Effectiveness of Anticholinergic Therapy for Overactive Bladder in Women: A Systematic Review and Meta‐Analysis,” Obstetrics & Gynecology 125 (2015): 1423–1432, https://doi.org/10.1097/aog.0000000000000851.
A. P. Cameron, “Medical Management of Neurogenic Bladder With Oral Therapy,” Translational Andrology and Urology 5 (2016): 51–62, https://doi.org/10.3978/j.issn.2223-4683.2015.12.07.
WHO Task Force, “Stroke—1989. Recommendations on Stroke Prevention, Diagnosis, and Therapy. Report of the WHO Task Force on Stroke and Other Cerebrovascular Disorders,” Stroke 20 (1989): 1407–1431, https://doi.org/10.1161/01.str.20.10.1407.
I. Glykas, C. Fragkoulis, D. D. Mitsikostas, et al., “B3 Agonists or Anticholinergics in the Treatment of the Lower Urinary Tract Dysfunction in Patients With Multiple Sclerosis?—A Randomized Study,” World Journal of Urology 39 (2021): 3049–3056, https://doi.org/10.1007/s00345-020-03555-8.
T. A. Zesiewicz, M. Evatt, C. P. Vaughan, et al., “Randomized, Controlled Pilot Trial of Solifenacin Succinate for Overactive Bladder in Parkinson's Disease,” Parkinsonism & Related Disorders 21 (2015): 514–520, https://doi.org/10.1016/j.parkreldis.2015.02.025.
M. Talebi, A. Pourmohammad, S. Tayebi, et al., “Psychometric Properties of the Persian Version of Neurogenic Bladder Symptom Score Questionnaire: A Methodological Study on Patients With Multiple Sclerosis and Stroke,” Neurourology and Urodynamics 41 (2022): 1817–1823, https://doi.org/10.1002/nau.25029.
R. Sari Motlagh, S. Hajebrahimi, H. Sadeghi‐Bazargani, and J. Tutunsaz, “Reliability and Validation of the International Consultation on Incontinence Questionnaire in Over Active Bladder to Persian Language: Validation of ICIQ‐OAB in Persian,” LUTS: Lower Urinary Tract Symptoms 7 (2014): 99–101, https://doi.org/10.1111/luts.1205.
A. A. Pourmomeny, M. Zargham, and M. Fani, “Reliability and Validity of the Quality of Life Questionnaire in Iranian Patients With Lower Urinary Tract Symptoms,” Lower Urinary Tract Symptoms 10 (2018): 93–100, https://doi.org/10.1111/luts.12147.
M. Trbovich, T. Romo, M. Polk, et al., “The Treatment of Neurogenic Lower Urinary Tract Dysfunction in Persons With Spinal Cord Injury: An Open Label, Pilot Study of Anticholinergic Agent Vs. Mirabegron to Evaluate Cognitive Impact and Efficacy,” Spinal Cord Series and Cases 7 (2021): 50, https://doi.org/10.1038/s41394-021-00413-6.
E. Fragalà, G. I. Russo, A. Di Rosa, et al., “Association Between the Neurogenic Bladder Symptom Score and Urodynamic Examination in Multiple Sclerosis Patients With Lower Urinary Tract Dysfunction,” International Neurourology Journal 19 (2015): 272–277, https://doi.org/10.5213/inj.2015.19.4.272.
D. A. Gelber, D. C. Good, L. J. Laven, and S. J. Verhulst, “Causes of Urinary Incontinence After Acute Hemispheric Stroke,” Stroke 24 (1993): 378–382, https://doi.org/10.1161/01.str.24.3.378.
A. Ruffion, D. Castro‐Diaz, H. Patel, et al., “Systematic Review of the Epidemiology of Urinary Incontinence and Detrusor Overactivity Among Patients With Neurogenic Overactive Bladder,” Neuroepidemiology 41 (2013): 146–155, https://doi.org/10.1159/000353274.
A. Ghavidel‐Sardsahra, M. Ghojazadeh, M. S. Rahnama'I, et al., “Efficacy of Percutaneous and Transcutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder and Interstitial Cystitis/Painful Bladder Syndrome: A Systematic Review and Meta‐Analysis,” Neurourology and Urodynamics 41 (2022): 539–551, https://doi.org/10.1002/nau.24864.
H. Chan, “Bladder Management in Acute Care of Stroke Patients: A Quality Improvement Project,” Journal of Neuroscience Nursing 29 (1997): 187–190, https://doi.org/10.1097/01376517-199706000-00006.
J. C. Gross, “Bladder Dysfunction After Stroke,” Urologic Nursing 12 (1992): 55–63.
Z. Mehdi, J. Birns, and A. Bhalla, “Post‐Stroke Urinary Incontinence,” International Journal of Clinical Practice 67 (2013): 1128–1137, https://doi.org/10.1111/ijcp.12183.
M. Pilcher and J. MacArthur, “Patient Experiences of Bladder Problems Following Stroke,” Nursing Standard (Royal College of Nursing (Great Britain): 1987) 26 (2012): 39–46, https://doi.org/10.7748/ns2012.05.26.36.39.c9087.
A. A. Alhasso, J. McKinlay, K. Patrick, and L. Stewart, “Anticholinergic Drugs Versus Non‐Drug Active Therapies for Overactive Bladder Syndrome in Adults,” Cochrane Database of Systematic Reviews 2006 (2006): CD003193, https://doi.org/10.1002/14651858.CD003193.pub3.
F. C. Hsu, C. E. Weeks, S. S. Selph, I. Blazina, R. S. Holmes, and M. S. McDonagh, “Updating the Evidence on Drugs to Treat Overactive Bladder: A Systematic Review,” International Urogynecology Journal 30 (2019): 1603–1617, https://doi.org/10.1007/s00192-019-04022-8.
D. Luo, L. Liu, P. Han, Q. Wei, and H. Shen, “Solifenacin for Overactive Bladder: A Systematic Review and Meta‐Analysis,” International Urogynecology Journal 23 (2012): 983–991, https://doi.org/10.1007/s00192-011-1641-7.
J. W. Noh, B. Lee, and J. H. Kim, “Efficacy and Safety of Anticholinergics for Children or Adolescents With Idiopathic Overactive Bladder: Systematic Review and Meta‐Analysis,” International Urology and Nephrology 51 (2019): 1459–1471, https://doi.org/10.1007/s11255-019-02209-y.
C. Roxburgh, J. Cook, and N. Dublin, “Anticholinergic Drugs Versus Other Medications for Overactive Bladder Syndrome in Adults,” Cochrane Database of Systematic Reviews 2007 (2007): CD003190, https://doi.org/10.1002/14651858.CD003190.pub4.
J. Hay‐Smith, P. Herbison, G. Ellis, and K. Moore, “Anticholinergic Drugs Versus Placebo for Overactive Bladder Syndrome in Adults,” Cochrane Database of Systematic Reviews 2002 (2002): CD003781, https://doi.org/10.1002/14651858.Cd003781.
G. Nabi, J. D. Cody, G. Ellis, P. Herbison, and J. Hay‐Smith, “Anticholinergic Drugs Versus Placebo for Overactive Bladder Syndrome in Adults,” Cochrane Database of Systematic Reviews 2006 (2006): CD003781, https://doi.org/10.1002/14651858.CD003781.pub2.
R. Scheife and M. Takeda, “Central Nervous System Safety of Anticholinergic Drugs for the Treatment of Overactive Bladder in the Elderly,” Clinical Therapeutics 27 (2005): 144–153, https://doi.org/10.1016/j.clinthera.2005.02.014.
V. K. Srivastava, S. Agrawal, S. A. Deshmukh, F. Noushad, S. Khan, and R. Kumar, “Efficacy of Trospium for Prevention of Catheter‐Related Bladder Discomfort: A Prospective, Randomized, Placebo‐Controlled, Double‐Blind Study,” Korean Journal of Anesthesiology 73 (2020): 145–150, https://doi.org/10.4097/kja.19198.
A. R. Moore and S. T. O'Keeffe, “Drug‐Induced Cognitive Impairment in the Elderly,” Drugs & Aging 15 (1999): 15–28.
K. Biastre and T. Burnakis, “Trospium Chloride Treatment of Overactive Bladder,” Annals of Pharmacotherapy 43 (2009): 283–295, https://doi.org/10.1345/aph.1L160.
H. Madersbacher and E. Rovner, “Trospium Chloride: The European Experience,” Expert Opinion on Pharmacotherapy 7 (2006): 1373–1380, https://doi.org/10.1517/14656566.7.10.1373.
D. R. Staskin, “Trospium Chloride: Distinct Among Other Anticholinergic Agents Available for the Treatment of Overactive Bladder,” Urologic Clinics of North America 33 (2006): 465–473, https://doi.org/10.1016/j.ucl.2006.06.006.
N. R. Zinner, “Trospium Chloride: An Anticholinergic Quaternary Ammonium Compound for the Treatment of Overactive Bladder,” Expert Opinion on Pharmacotherapy 6 (2005): 1409–1420, https://doi.org/10.1517/14656566.6.8.1409.
J. Jayarajan and S. B. Radomski, “Pharmacotherapy of Overactive Bladder in Adults: A Review of Efficacy, Tolerability, and Quality of Life,” Research and Reports in Urology 6 (2013): 1–16, https://doi.org/10.2147/rru.S40034.
C. R. Chapple, T. Rechberger, S. Al‐Shukri, et al., “Randomized, Double‐Blind Placebo‐ and Tolterodine‐Controlled Trial of the Once‐Daily Antimuscarinic Agent Solifenacin in Patients With Symptomatic Overactive Bladder,” BJU International 93 (2004): 303–310, https://doi.org/10.1111/j.1464-410x.2004.04606.x.
N. Buser, S. Ivic, T. M. Kessler, A. G. H. Kessels, and L. M. Bachmann, “Efficacy and Adverse Events of Antimuscarinics for Treating Overactive Bladder: Network Meta‐Analyses,” European Urology 62 (2012): 1040–1060, https://doi.org/10.1016/j.eururo.2012.08.060.