Page last updated: 2024-12-05

propiverine

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Description

Propiverine is an antispasmodic medication primarily used to treat overactive bladder. It acts by relaxing the smooth muscles of the bladder, reducing urinary frequency and urgency. Its synthesis involves a multi-step process, starting with the reaction of 2-chloro-4-methyl-6-phenylpyrimidine with 3-methoxypropan-1-ol. Propiverine's effects are related to its interaction with muscarinic receptors, specifically M2 and M3 receptors, which are involved in bladder muscle contraction. Research into propiverine focuses on understanding its therapeutic efficacy, safety profile, and potential for treating other conditions, such as irritable bowel syndrome and chronic pain. It is studied due to its potential for improving bladder function, reducing symptoms, and improving quality of life for patients with overactive bladder.'

propiverine: anticholinergic used for overactive bladder syndrome [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID4942
CHEMBL ID1078261
CHEBI ID8493
SCHEMBL ID94695
MeSH IDM0064951

Synonyms (38)

Synonym
propiverine
60569-19-9
C07852
1-methyl-4-piperidyl diphenylpropoxyacetate
propiverine [inn]
benzeneacetic acid, alpha-phenyl-alpha-propoxy-, 1-methyl-4-piperidinyl ester
1-methyl-4-piperidyl 2,2-diphenyl-2-propoxyacetate
1-methyl-4-piperidyl o-propylbenzilate
propiverinum [inn-latin]
propiverino [inn-spanish]
1-methyl-4-piperidinyl alpha-phenyl-alpha-propoxybenzeneacetate
D08441
propiverine (inn)
chebi:8493 ,
CHEMBL1078261
(1-methylpiperidin-4-yl) 2,2-diphenyl-2-propoxyacetate
AKOS016012153
propiverine [inn:ban]
propiverino
propiverinum
468ge2241l ,
unii-468ge2241l
FT-0630722
propiverine [who-dd]
propiverine [mi]
1-methylpiperidin-4-yl 2,2-diphenyl-2-propoxyacetate
SCHEMBL94695
(1-methyl-4-piperidyl) 2,2-diphenyl-2-propoxy-acetate
DTXSID5048265
diphenylpropoxyacetic acid, 1-methylpiperidin-4-yl ester
diphenyl-propoxyessigsaeure-1-methylpiperidin-4-ylester
1-methyl-4-piperidinyl diphenyl(propoxy)acetate #
DB12278
Q904321
A903955
HY-116408
CS-0065396
EN300-25916822

Research Excerpts

Overview

Propiverine hydrochloride is an example of a drug with a bitter taste, used for the treatment of overactive bladders. Propiverine is a muscarinic receptor antagonist possessing additional properties, i.e., block of L-type Ca(2+) channels.

ExcerptReferenceRelevance
"Propiverine hydrochloride is an example of a drug with a bitter taste, used for the treatment of overactive bladders."( Enhancing the solubility and masking the bitter taste of propiverine using crystalline complex formation.
Ogata, T; Ozeki, T; Tanaka, D, 2014
)
1.37
"Propiverine is a widely used antimuscarinic drug with bioavailability that is limited by intestinal first-pass extraction. "( Modeling the heterogeneous intestinal absorption of propiverine extended-release.
Sermsappasuk, P; Siegmund, W; Weiss, M, 2015
)
2.11
"Propiverine is a muscarinic receptor antagonist possessing additional properties, i.e., block of L-type Ca(2+) channels."( The muscarinic receptor antagonist propiverine exhibits α(1)-adrenoceptor antagonism in human prostate and porcine trigonum.
Braeter, M; Michel, MC; Michel-Reher, MB; Propping, S; Ravens, U; Strugala, GJ; Wirth, MP; Witte, LP; Wuest, M, 2011
)
1.37
"Propiverine is a well established antimuscarinic agent with a mixed mode of action in the treatment of symptoms associated with overactive bladder (OAB). "( Propiverine: a review of its use in the treatment of adults and children with overactive bladder associated with idiopathic or neurogenic detrusor overactivity, and in men with lower urinary tract symptoms.
McKeage, K, 2013
)
3.28
"Propiverine hydrochloride is a preferable alternative to oxybutynin, the anticholinergic most frequently used in children with NDO to date."( Urodynamic effects of propiverine hydrochloride in children with neurogenic detrusor overactivity: a prospective analysis.
Henne, T; Knispel, HH; Michael, T; Miller, K; Mürtz, G; Schulte-Baukloh, H, 2006
)
1.37
"Propiverine is a commonly used antimuscarinic drug used as therapy for symptoms of an overactive bladder. "( Propiverine and metabolites: differences in binding to muscarinic receptors and in functional models of detrusor contraction.
Braeter, M; Hakenberg, OW; Kelly, LU; Ravens, U; Waelbroeck, M; Weiss, A; Wuest, M, 2006
)
3.22
"Propiverine is a drug for the treatment of incontinence and pollakiuria. "( [Effects of propiverine hydrochloride (propiverine) on isolated rat and dog urinary bladder].
Kaneko, S; Nakano, D; Nishimori, T; Ohara, M, 1999
)
2.13
"Propiverine is a drug for the treatment of incontinence and pollakiuria. "( [Effects of propiverine hydrochloride (propiverine) on the muscarinic receptor binding affinity in guinea pig tissues and on salivation in conscious dogs].
Hirota, T; Isogai, M; Kaneko, S; Nagao, M; Shimizu, H, 1999
)
2.13
"Propiverine is a safe and effective drug in the treatment of urgency and urge incontinence; it is as effective as oxybutynin, but the incidence of dry mouth and its severity is less with propiverine than with oxybutynin. "( A placebo-controlled, multicentre study comparing the tolerability and efficacy of propiverine and oxybutynin in patients with urgency and urge incontinence.
Alloussi, S; Halaska, M; Höfner, K; Madersbacher, H; Voigt, R, 1999
)
1.97

Treatment

Propiverine treatment that increases plasma catecholamine levels could contribute to improvement of SUI conditions. Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate.

ExcerptReferenceRelevance
"Propiverine treatment that increases plasma catecholamine levels could contribute to improvement of SUI conditions by increasing urethral resistance."( Effects of propiverine hydrochloride, an anticholinergic agent, on urethral continence mechanisms and plasma catecholamine concentration in rats.
Kiniwa, M; Kitta, T; Nanri, M; Nonomura, K; Tyagi, V; Yoshimura, N, 2013
)
2.22
"Treatment with propiverine hydrochloride alleviated urinary incontinence while improving patient symptoms and quality of life after RALP or LRP."( Efficacy of propiverine hydrochloride for urinary incontinence after robot-assisted or laparoscopic radical prostatectomy.
Matsuo, T; Mitsunari, K; Miyata, Y; Mukae, Y; Ohba, K; Sakai, H, 2021
)
1.35
"Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate."( Comparison of the efficacy, safety, and tolerability of propiverine and oxybutynin for the treatment of overactive bladder syndrome.
Abrams, P; Cardozo, L; Chapple, C; Hargreaves, K; Khullar, V; Serdarevic, D, 2006
)
0.92
"Pretreatment with propiverine and tolterodine caused parallel shifts to the right of the concentration-response curves to carbachol. "( Pharmacological effects of propiverine and its active metabolite, M-1, on isolated human urinary bladder smooth muscle, and on bladder contraction in rats.
Inadome, A; Maeda, Y; Masunaga, K; Nagata, T; Satoji, Y; Sugiyama, Y; Ueda, S; Yoshida, M, 2008
)
0.98

Toxicity

There was a significantly more favourable tolerability to propiverine than oxybutynin. The incidence of adverse events was very low (2% dryness of the mouth) and confirmed by the findings from the quality of life questionnaires.

ExcerptReferenceRelevance
" The LD50 values of P-4 were as follows: Mice; 410 (male) and 323 (female) mg/kg in oral route, 223 (male) and 283 (female) mg/kg in subcutaneous route and 36 (male and female) mg/kg in intravenous route, Rats; 1000 (male) and 1092 (female) mg/kg in oral route, 1632 (male) and 1411 (female) mg/kg in subcutaneous route, and 22 (male) and 25 (female) mg/kg in intravenous route."( [Acute toxicity studies of propiverine hydrochloride].
Irimura, K; Kuwata, M; Morinaga, H; Morita, K; Nakano, S; Yada, H; Yamashita, K, 1989
)
0.57
" As a toxic sign, only the frequency of vomiting was increased in animals of 1, 3 and 9 mg/kg/day groups."( [One-year chronic oral toxicity study of propiverine hydrochloride in dogs followed by one-month recovery].
Kohda, S; Kuroda, J; Miura, K; Narama, I; Nishikawa, H; Sano, M; Sumino, M; Tsuchitani, M; Yada, H; Yamashita, K, 1989
)
0.54
" In the kidney, eosinophilic and intranuclear inclusions in the tubular epithelium were detected, in which cytoplasm there were no toxic injuries, in males given 10 mg/kg/day or more and females given 50 mg/kg/day or more."( [Thirteen-week oral toxicity study of propiverine hydrochloride in rats].
Hasegawa, H; Irimura, K; Kuwata, M; Maruden, A; Morita, K; Nakano, S, 1989
)
0.55
" Adverse events were reported by 12 patients."( Pharmacokinetics and safety of propiverine in patients with fatty liver disease.
Kirch, W; Nokhodian, A; Siepmann, M; Thümmler, D,
)
0.42
" For the evaluation of the safety of propiverine the incidence rate of adverse events by directly questioning as well as laboratory parameters were investigated."( Efficacy and safety of propiverine in SCI-patients suffering from detrusor hyperreflexia--a double-blind, placebo-controlled clinical trial.
Dreikorn, K; Madersbacher, H; Richter, R; Stöhrer, M; Wehnert, J, 1999
)
0.89
" Expected anticholinergic adverse events occurred: dryness of the mouth (37% in the verum and 8% in the placebo group), accommodation disorders (28% and 2% respectively)."( Efficacy and safety of propiverine in SCI-patients suffering from detrusor hyperreflexia--a double-blind, placebo-controlled clinical trial.
Dreikorn, K; Madersbacher, H; Richter, R; Stöhrer, M; Wehnert, J, 1999
)
0.61
" Anticholinergic adverse events such as dryness of the mouth and accommodation disorders were considered being tolerable."( Efficacy and safety of propiverine in SCI-patients suffering from detrusor hyperreflexia--a double-blind, placebo-controlled clinical trial.
Dreikorn, K; Madersbacher, H; Richter, R; Stöhrer, M; Wehnert, J, 1999
)
0.61
" The incidence of adverse events was very low (2% dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires."( Efficacy and cardiac safety of propiverine in elderly patients - a double-blind, placebo-controlled clinical study.
Dorschner, W; Frank, M; Griebenow, R; Halaska, M; Mürtz, G; Schubert, G; Stolzenburg, JU; Wieners, F, 2000
)
0.82
" Voigt reported an adverse event incidence rate of 13% in a follow-up investigation during 10 years of treatment."( Efficacy, tolerability and safety profile of propiverine in the treatment of the overactive bladder (non-neurogenic and neurogenic).
Madersbacher, H; Mürtz, G, 2001
)
0.57
" The incidence of adverse events was very low (2 % dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires."( [The elderly patient with urge incontinence or urge-stress incontinence - efficacy and cardiac safety of propiverine].
Brünjes, R; Dorschner, W; Frank, M; Griebenow, R; Halaska, M; Stolzenburg, JU; Wieners, F, 2003
)
0.76
" One patient spontaneously reported a typical anticholinergic adverse event, which resolved after dose reduction."( Efficacy, tolerability and safety of propiverine hydrochloride in children and adolescents with congenital or traumatic neurogenic detrusor overactivity--a retrospective study.
Goepel, M; Grigoleit, U; Kramer, G; Laschke, S; Mürtz, G; Schuldt, M; Stöhrer, M, 2006
)
0.61
"5%) of adverse events evidences a favourable risk-benefit profile of propiverine hydrochloride, considering in particular the total documented treatment and surveillance period of 171 patient years and nine months."( Efficacy, tolerability and safety of propiverine hydrochloride in children and adolescents with congenital or traumatic neurogenic detrusor overactivity--a retrospective study.
Goepel, M; Grigoleit, U; Kramer, G; Laschke, S; Mürtz, G; Schuldt, M; Stöhrer, M, 2006
)
0.84
" The primary differences between the two drugs were the incidence and type of adverse events, which varied with the antimuscarinic receptor specificity of each agent."( Comparison of the efficacy, safety, and tolerability of propiverine and oxybutynin for the treatment of overactive bladder syndrome.
Abrams, P; Cardozo, L; Chapple, C; Hargreaves, K; Khullar, V; Serdarevic, D, 2006
)
0.58
" The incidence of adverse events was 23."( [Efficacy and safety of propiverine on improvement of symptoms and QOL for female patients with wet overactive bladder].
Gotoh, M; Hattori, R; Kato, K; Kato, M; Kondo, A; Matsukawa, Y; Yamada, S, 2008
)
0.65
" Tolerability was evaluated by the rate of adverse events, adverse drug reactions caused by antimuscarinics and premature treatment termination."( Efficacy, tolerability and safety of propiverine hydrochloride in comparison to oxybutynin in children with urge incontinence due to overactive bladder: Results of a multicentre observational cohort study.
Alloussi, S; Bock, P; Braun, R; Gerhardt, U; Heinrich, M; Hellmis, E; Horn, W; Madersbacher, H; Marschall-Kehrel, D; Mürtz, G; Niklas, K; Raabe, M; Rössler, T; Schultz-Lampel, D; Seibt, B; Siemer, S; Strugala, G; Walter, H; Wiedeking, B, 2010
)
0.63
" There was a significantly more favourable tolerability to propiverine than oxybutynin for the overall rate of adverse events (3."( Efficacy, tolerability and safety of propiverine hydrochloride in comparison to oxybutynin in children with urge incontinence due to overactive bladder: Results of a multicentre observational cohort study.
Alloussi, S; Bock, P; Braun, R; Gerhardt, U; Heinrich, M; Hellmis, E; Horn, W; Madersbacher, H; Marschall-Kehrel, D; Mürtz, G; Niklas, K; Raabe, M; Rössler, T; Schultz-Lampel, D; Seibt, B; Siemer, S; Strugala, G; Walter, H; Wiedeking, B, 2010
)
0.88
" The AMs used to treat OAB differ in their pharmacological profiles, which may affect their potential for causing adverse effects (AEs)."( Pharmacokinetics and toxicity of antimuscarinic drugs for overactive bladder treatment in females.
Alessandri, F; Candiani, M; Ferrero, S; Leone Roberti Maggiore, U; Origoni, M; Remorgida, V; Salvatore, S; Venturini, PL, 2012
)
0.38
"1-week treatment with P4 appeared to be safe 1) in OAG patients treated with topical β-blockers and 2) in NAG patients treated with topical pilocarpine ± β-blockers, irrespective of whether the eyes had previously been treated with glaucoma surgery or laser therapy."( Ocular safety of propiverine hydrochloride in elderly patients with primary open- and narrow-angle glaucoma
.
Braeter, M; de Mey, C; Gatchev, E; Petkova, N, 2016
)
0.77
" Safety assessments included treatment-emergent adverse events, vital signs, 12-lead electrocardiograms, post-void residual volume, and laboratory evaluations."( Long-term safety and efficacy of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A multicenter, randomized study in Japan (MILAI II study).
Gotoh, M; Hamada, T; Homma, Y; Igawa, Y; Kakizaki, H; Kobayashi, A; Kuroishi, K; Nishizawa, O; Okitsu, A; Seki, N; Takeda, M; Yamaguchi, O; Yokoyama, O; Yoshida, M, 2019
)
0.51
"1% women, mean age 65 years) experienced at least one treatment-emergent adverse event, with similar rates for all treatments."( Long-term safety and efficacy of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A multicenter, randomized study in Japan (MILAI II study).
Gotoh, M; Hamada, T; Homma, Y; Igawa, Y; Kakizaki, H; Kobayashi, A; Kuroishi, K; Nishizawa, O; Okitsu, A; Seki, N; Takeda, M; Yamaguchi, O; Yokoyama, O; Yoshida, M, 2019
)
0.51
" CV safety was assessed using treatment-emergent adverse events (TEAEs), vital signs, and 12-lead electrocardiograms (ECGs)."( Cardiovascular safety of antimuscarinic add-on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A post hoc analysis from the Japanese MILAI II study.
Hamada, T; Igawa, Y; Kato, D; Katoh, T; Kuroishi, K; Yamaguchi, O, 2020
)
0.56

Pharmacokinetics

No significant differences were observed for propiverine and its main metabolite with regard to peak serum concentration. Propiverine was eliminated from the plasma with a half-life time (t0)

ExcerptReferenceRelevance
" Propiverine was eliminated from the plasma with a half-life time (t0."( On the pharmacokinetics and metabolism of propiverine in man.
Haustein, KO; Hüller, G,
)
1.31
"No significant differences were observed for propiverine and its main metabolite with regard to peak serum concentration (Cmax), area under the serum concentration-time curve (AUC) and elimination half-life (t1/2)."( Pharmacokinetics and safety of propiverine in patients with fatty liver disease.
Kirch, W; Nokhodian, A; Siepmann, M; Thümmler, D,
)
0.68
"No pharmacokinetic differences relevant for safety were observed, comparing patients with and without fatty liver disease following repeated oral administration of propiverine."( Pharmacokinetics and safety of propiverine in patients with fatty liver disease.
Kirch, W; Nokhodian, A; Siepmann, M; Thümmler, D,
)
0.61
" The urodynamic measurements as well as pharmacokinetic samplings were done before the medication, 4 weeks and 8 weeks after the starting medication, to examine the dose-response and concentration-response relationships."( [Pharmacological evaluation of efficacy and safety of propiverine hydrochloride in patients of overactive bladder--relationship between urodynamic observation and propiverine pharmacokinetics--].
Hanai, T; Hashimoto, K; Matsumoto, S; Shimizu, N; Sugiyama, T; Uemura, H; Yoshioka, N, 2005
)
0.58
" Higher doses did not result in additional dose-proportional increases in the respective pharmacokinetic parameters, particularly not after repeated-dose treatment."( Pharmacokinetics and pharmacodynamics of propiverine in children aged between 5 and 10 years with symptoms of overactive bladder.
Feustel, C; Läckgren, G; Mürtz, G; Schnabel, F; Siegmund, W; Sillén, U, 2010
)
0.63
" The method was proved to be rapid, sensitive, specific, accurate and reproducible and has been successfully applied to a pharmacokinetic study of propiverine hydrochloride sustained release capsules (the 30 mg dose in this study is related to 30 mg of salt (propiverine hydrochloride))."( Determination of propiverine hydrochloride in human plasma by high performance liquid chromatography-tandem mass spectrometry: application to the pharmacokinetic study of a sustained release formulation.
Huang, M; Lin, H; Tian, Y; Zhang, H; Zhang, Z, 2011
)
0.91

Bioavailability

Propiverine is a widely used antimuscarinic drug with bioavailability that is limited by intestinal first-pass extraction. The bioavailability of propiverine appears to be dependent on the intestinal site of dissolution and on the extent of presystemic intestinal elimination.

ExcerptReferenceRelevance
" The aim of our study with propiverine IR and extended release (ER) was to determine whether propiverine disposition is dose linear, to compare the pharmacokinetics of propiverine in oral solution with IR and ER and to show how absorption rate is associated with bioavailability."( Oral absorption of propiverine solution and of the immediate and extended release dosage forms: influence of regioselective intestinal elimination.
Braeter, M; Giessmann, T; May, K; Modess, C; Oertel, R; Oswald, S; Siegmund, W; Wegner, D, 2008
)
0.97
" The bioavailability of ER was 64."( Oral absorption of propiverine solution and of the immediate and extended release dosage forms: influence of regioselective intestinal elimination.
Braeter, M; Giessmann, T; May, K; Modess, C; Oertel, R; Oswald, S; Siegmund, W; Wegner, D, 2008
)
0.67
"The bioavailability of propiverine appears to be dependent on the intestinal site of dissolution and, consequently, on the extent of presystemic intestinal elimination."( Oral absorption of propiverine solution and of the immediate and extended release dosage forms: influence of regioselective intestinal elimination.
Braeter, M; Giessmann, T; May, K; Modess, C; Oertel, R; Oswald, S; Siegmund, W; Wegner, D, 2008
)
0.99
"The muscarinic receptor antagonist propiverine is unique insofar as extended-release (ER) tablets are of higher bioavailability than immediate-release (IR) tablets; this is caused by lower "first-pass" elimination of propiverine via CYP3A4 and efflux transporters in the distal small intestine and colon."( Influence of a fat-rich meal on bioavailability of extended-release and immediate-release propiverine.
Feustel, C; Kirch, W; Richter, K; Schnabel, F; Siegert, J; Siegmund, W, 2012
)
0.88
" The dissolution rate and bioavailability of fine granules of the free base were compared with tablets of P-4."( Taste masking of propiverine hydrochloride by conversion to its free base.
Kinoshita, M; Koide, A; Ogata, T; Ozeki, T, 2012
)
0.72
"Propiverine is a widely used antimuscarinic drug with bioavailability that is limited by intestinal first-pass extraction."( Modeling the heterogeneous intestinal absorption of propiverine extended-release.
Sermsappasuk, P; Siegmund, W; Weiss, M, 2015
)
2.11
"The extent and rate of bioavailability are fundamental measures to characterize the pharmacokinetics of drugs after oral administration."( Dependence of Bioavailability on Mean Absorption Time: What Does It Tell Us?
Siegmund, W; Weiss, M, 2023
)
0.91

Dosage Studied

The present study was designed to assess the pharmacokinetics of propiverine after single and multiple dosing in patients with and without fatty liver disease. At doses of 10(-6)-3 x 10(-5) M, propiverin caused both a rightward shift and inhibition of the maximum response in the acetylcholine (ACh) dose-response curve. We concluded that oral absorption of Propiverine is site-dependent and influenced by dosage form and circadian-time-dependent elimination processes.

ExcerptRelevanceReference
" During administration and recovery period, no death occurred in any dosed animals."( [One-year chronic oral toxicity study of propiverine hydrochloride in dogs followed by one-month recovery].
Kohda, S; Kuroda, J; Miura, K; Narama, I; Nishikawa, H; Sano, M; Sumino, M; Tsuchitani, M; Yada, H; Yamashita, K, 1989
)
0.54
" The application period was 4 weeks and the dosage was 45 mg/d Mictonorm and 300 mg/d Spasuret, respectively."( [Comparative studies of the effect of mictonorm (propiverin hydrochloride) and Spasuret (flavoxate hydrochloride) on the bladder detrusor muscle].
Sage, S; Wehnert, J, 1989
)
0.28
" At doses of 10(-6) or 10(-5) M, P-4 shifted the dose-response curve for acetylcholine (ACh) to the right, and at a dose of 10(-5) M, it also inhibited the maximum response of ACh."( [Effects of propiverine hydrochloride and its metabolites on isolated guinea pig urinary bladder].
Haruno, A; Iriki, M; Kosaka, M; Miyake, H; Miyoshi, K; Nagai, M; Tsuchiya, K; Yamasaki, Y, 1989
)
0.66
" Mictonorm was given for 3 months, in a dosage of 0,4 mg/kg bw/d."( [Treatment of the unstable bladder in children with the anticholinergic agent propiverin hydrochloride (mictonorm/mictonets)].
Otto-Unger, G, 1985
)
0.27
" Individual treatment with an initial dosage of 30 mg/d should be recommended."( Clinical and urodynamic effects of propiverine in patients suffering from urgency and urge incontinence. A multicentre dose-optimizing study.
Alken, RG; Dorschner, W; Herfurth, G; Mazur, D; Schubert, G; Wehnert, J, 1995
)
0.57
"The present study was designed to assess the pharmacokinetics of propiverine after single and multiple dosing in patients with and without fatty liver disease."( Pharmacokinetics and safety of propiverine in patients with fatty liver disease.
Kirch, W; Nokhodian, A; Siepmann, M; Thümmler, D,
)
0.66
" At doses of 10(-6)-3 x 10(-5) M, propiverine caused both a rightward shift and inhibition of the maximum response in the acetylcholine (ACh) dose-response curve."( [Effects of propiverine hydrochloride (propiverine) on isolated rat and dog urinary bladder].
Kaneko, S; Nakano, D; Nishimori, T; Ohara, M, 1999
)
0.96
" The dosages were selected specifically to compare the tolerability profile of propiverine with the commonly used therapeutic dosage of oxybutynin."( A placebo-controlled, multicentre study comparing the tolerability and efficacy of propiverine and oxybutynin in patients with urgency and urge incontinence.
Alloussi, S; Halaska, M; Höfner, K; Madersbacher, H; Voigt, R, 1999
)
0.76
" The urodynamic measurements as well as pharmacokinetic samplings were done before the medication, 4 weeks and 8 weeks after the starting medication, to examine the dose-response and concentration-response relationships."( [Pharmacological evaluation of efficacy and safety of propiverine hydrochloride in patients of overactive bladder--relationship between urodynamic observation and propiverine pharmacokinetics--].
Hanai, T; Hashimoto, K; Matsumoto, S; Shimizu, N; Sugiyama, T; Uemura, H; Yoshioka, N, 2005
)
0.58
" However, no apparent dose-response relationships were observed for maximum urinary flow rate and the detrusor pressure at the maximum urinary flow rate."( [Pharmacological evaluation of efficacy and safety of propiverine hydrochloride in patients of overactive bladder--relationship between urodynamic observation and propiverine pharmacokinetics--].
Hanai, T; Hashimoto, K; Matsumoto, S; Shimizu, N; Sugiyama, T; Uemura, H; Yoshioka, N, 2005
)
0.58
"Although the anticholinergic dosage was low, the present results suggest that naftopidil monotherapy was as useful as combination therapy of naftopidil and an anticholinergic agent."( Naftopidil monotherapy vs naftopidil and an anticholinergic agent combined therapy for storage symptoms associated with benign prostatic hyperplasia: A prospective randomized controlled study.
Hanazawa, K; Honda, S; Kawachi, Y; Koizumi, K; Maruyama, O; Noto, K; Saitoh, T; Sugimura, S; Sugiyama, Y; Yamashita, R, 2006
)
0.33
" We concluded that oral absorption of propiverine is site-dependent and influenced by dosage form and circadian-time-dependent elimination processes."( Disposition and antimuscarinic effects of the urinary bladder spasmolytics propiverine: influence of dosage forms and circadian-time rhythms.
Adam, U; Braeter, M; Giessmann, T; Lerch, MM; May, K; Oertel, R; Siegmund, W; Warzok, RW; Wegner, D; Weitschies, W; Westphal, K, 2008
)
0.85
" Moreover, other ECG parameters like QT dispersion, T-wave shape, and U-wave occurrence were not affected by propiverine compared to placebo after single or repeated dosing to reach steady-state conditions."( The influence of propiverine hydrochloride on cardiac repolarization in healthy women and cardiac male patients.
Braeter, M; Donath, F; Feustel, C, 2011
)
0.92
" Profiles of each drug and dosage differ and should be considered in making treatment choices."( An overview on mixed action drugs for the treatment of overactive bladder and detrusor overactivity.
Artibani, W; Asimakopoulos, AD; Carone, R; Cerruto, MA; Del Popolo, G; Finazzi-Agrò, E; La Martina, M, 2012
)
0.38
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
diarylmethaneAny compound containing two aryl groups connected by a single C atom.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (3)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency0.89130.035520.977089.1251AID504332
gemininHomo sapiens (human)Potency31.67680.004611.374133.4983AID624296; AID624297
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency32.19680.005612.367736.1254AID624032
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (5)

Assay IDTitleYearJournalArticle
AID467611Dissociation constant, pKa of the compound2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (225)

TimeframeStudies, This Drug (%)All Drugs %
pre-199042 (18.67)18.7374
1990's29 (12.89)18.2507
2000's84 (37.33)29.6817
2010's65 (28.89)24.3611
2020's5 (2.22)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 51.92

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index51.92 (24.57)
Research Supply Index5.66 (2.92)
Research Growth Index4.67 (4.65)
Search Engine Demand Index83.55 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (51.92)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials55 (23.91%)5.53%
Reviews14 (6.09%)6.00%
Case Studies2 (0.87%)4.05%
Observational0 (0.00%)0.25%
Other159 (69.13%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (13)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis [NCT03844581]40 participants (Actual)Interventional2019-01-01Completed
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania [NCT03602508]5,589 participants (Actual)Observational2018-07-20Completed
Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder) [NCT00795925]Phase 230 participants (Actual)Interventional2004-10-31Completed
A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China [NCT03572231]805 participants (Actual)Observational2018-07-19Completed
Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB) [NCT00646880]Phase 341 participants (Actual)Interventional2003-03-31Completed
Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder: PRopiverine Study on Overactive Bladder Including Urgency Data (PROUD) [NCT00903045]Phase 4264 participants (Actual)Interventional2005-01-31Completed
Multi-institution Study on Efficacy and Safety of Propiverine Hydrochloride for Female Patients With Urge and Stress Urinary Incontinence [NCT01942681]62 participants (Actual)Interventional2013-09-30Completed
Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial [NCT00603343]Phase 3303 participants (Actual)Interventional2004-06-30Completed
Evaluation of Health-Related Quality of Life in Patients With Overactive Bladder Syndrome (OAB) Treated With Propiverine, and Its Efficacy and Tolerance in Daily Practice in Belgian General Practitioners and Urologists [NCT02024945]437 participants (Actual)Observational2010-11-30Completed
Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence [NCT01512004]Phase 3324 participants (Actual)Interventional2010-01-31Completed
Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial [NCT01530620]Phase 366 participants (Actual)Interventional2004-12-31Completed
Urinary NGF, PGE2 and ATP: Potential Biomarkers for Diagnosis and Prediction of Treatment Efficacy in Overactive Bladder Patients [NCT01499069]191 participants (Actual)Interventional2010-02-28Completed
Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron [NCT02294396]Phase 4649 participants (Actual)Interventional2014-10-28Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT02294396 (16) [back to overview]Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours
NCT02294396 (16) [back to overview]Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Number of Participants Who Achieved Normalization for OABSS Total Score
NCT02294396 (16) [back to overview]Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in OAB-q SF Total HRQL Score
NCT02294396 (16) [back to overview]Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score
NCT02294396 (16) [back to overview]Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
NCT02294396 (16) [back to overview]Change From Baseline in Postvoid Residual (PVR) Volume
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Micturitions Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Nocturia Episodes Per Night
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours
NCT02294396 (16) [back to overview]Change From Baseline in the Mean Volume Voided Per Micturition
NCT02294396 (16) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours

Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin61
Mirabegron + Propiverine61
Mirabegron + Imidafenacin69
Mirabegron + Tolterodine71

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Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours

Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin60
Mirabegron + Propiverine47
Mirabegron + Imidafenacin47
Mirabegron + Tolterodine51

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Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours

Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin70
Mirabegron + Propiverine77
Mirabegron + Imidafenacin64
Mirabegron + Tolterodine76

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Number of Participants Who Achieved Normalization for OABSS Total Score

Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin98
Mirabegron + Propiverine101
Mirabegron + Imidafenacin91
Mirabegron + Tolterodine96

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Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours

Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours. (NCT02294396)
Timeframe: Week 52 (end of treatment)

InterventionParticipants (Count of Participants)
Mirabegron + Solifenacin26
Mirabegron + Propiverine21
Mirabegron + Imidafenacin21
Mirabegron + Tolterodine14

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Change From Baseline in OAB-q SF Total HRQL Score

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT02294396)
Timeframe: Baseline and week 12, 28 and 52

,,,
Interventionunits on a scale (Mean)
Week 12Week 28Week 52End of treatment
Mirabegron + Imidafenacin11.0614.8814.6713.99
Mirabegron + Propiverine11.3513.0513.8912.46
Mirabegron + Solifenacin12.0715.1515.9914.38
Mirabegron + Tolterodine12.0512.9415.0614.36

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Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score

The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Symptom Severity and the Health-related Quality of Life (HRQL). The Symptom Severity section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline. (NCT02294396)
Timeframe: Baseline and week 12, 28 and 52

,,,
Interventionunits on a scale (Mean)
Week 12Week 28Week 52End of treatment
Mirabegron + Imidafenacin-17.15-20.40-20.51-18.89
Mirabegron + Propiverine-20.2-21.40-20.68-18.99
Mirabegron + Solifenacin-18.59-21.38-20.55-18.92
Mirabegron + Tolterodine-21.22-21.95-22.49-21.28

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Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score

The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28 and 52

,,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 28Week 52End of treatment
Mirabegron + Imidafenacin-2.4-3.1-3.4-3.8-3.9-4.1-3.9
Mirabegron + Propiverine-3.1-3.7-4.2-4.4-4.4-4.1-4.1
Mirabegron + Solifenacin-2.9-3.5-4.0-4.1-4.0-4.0-3.9
Mirabegron + Tolterodine-3.0-3.5-4.0-4.4-4.3-4.3-4.2

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Change From Baseline in Postvoid Residual (PVR) Volume

Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study. (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,
InterventionmL (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of treatment
Mirabegron + Imidafenacin6.815.777.194.042.972.795.562.192.185.193.142.222.844.52
Mirabegron + Propiverine9.993.233.671.063.534.033.871.340.663.291.030.714.586.83
Mirabegron + Solifenacin9.0710.684.727.512.324.992.950.704.116.032.172.603.568.17
Mirabegron + Tolterodine8.218.396.048.674.681.465.073.113.125.400.502.332.025.94

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Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionincontinence episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-0.81-0.74-0.86-0.97-0.99-0.96-1.02-1.03
Mirabegron + Propiverine-1.06-1.21-1.34-1.32-1.28-1.28-1.29-1.18
Mirabegron + Solifenacin-1.13-1.16-1.27-1.23-1.31-1.23-1.31-1.25
Mirabegron + Tolterodine-1.09-1.21-1.23-1.33-1.28-1.07-1.18-1.15

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Change From Baseline in the Mean Number of Micturitions Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionmicturitions (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-1.23-1.62-1.74-1.86-1.97-1.80-1.82-1.75
Mirabegron + Propiverine-1.44-1.89-1.90-2.21-2.10-1.97-2.08-1.89
Mirabegron + Solifenacin-1.57-1.85-2.04-2.33-2.29-2.12-2.29-2.18
Mirabegron + Tolterodine-1.51-1.72-2.18-2.202.33-1.92-1.80-1.91

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Change From Baseline in the Mean Number of Nocturia Episodes Per Night

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionnocturia episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-0.32-0.42-0.45-0.54-0.48-0.39-0.53-0.48
Mirabegron + Propiverine-0.29-0.37-0.28-0.37-0.39-0.45-0.44-0.38
Mirabegron + Solifenacin-0.33-0.42-0.45-0.49-0.42-0.53-0.55-0.47
Mirabegron + Tolterodine-0.49-0.44-0.47-0.50-0.54-0.54-0.50-0.48

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Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionurge incontinence episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-0.72-0.71-0.79-0.87-0.85-0.91-0.93-0.91
Mirabegron + Propiverine-1.00-1.14-1.25-1.22-1.10-1.14-1.14-1.12
Mirabegron + Solifenacin-1.13-1.15-1.20-1.17-1.26-1.19-1.23-1.20
Mirabegron + Tolterodine-0.96-1.05-1.13-1.22-1.18-1.07-1.15-1.05

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Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
Interventionurgency episodes (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin-1.23-1.50-1.88-2.01-2.18-2.14-2.15-2.04
Mirabegron + Propiverine-1.63-1.90-2.18-2.36-2.26-2.27-2.33-2.24
Mirabegron + Solifenacin-1.53-1.78-2.06-2.30-2.28-2.14-2.04-2.03
Mirabegron + Tolterodine-1.49-1.89-2.10-2.26-2.28-2.19-2.26-2.07

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Change From Baseline in the Mean Volume Voided Per Micturition

"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis." (NCT02294396)
Timeframe: Baseline and week 4, 8, 12, 16, 28, 40, 52

,,,
InterventionmL (Mean)
Week 4Week 8Week 12Week 16Week 28Week 40Week 52End of treatment
Mirabegron + Imidafenacin20.06223.82027.07224.48929.87329.82636.65332.854
Mirabegron + Propiverine30.11138.61441.43340.66141.88743.10240.59938.691
Mirabegron + Solifenacin30.67738.32839.45239.95236.02543.57841.74440.004
Mirabegron + Tolterodine32.85435.35136.59837.78634.82341.37840.54840.683

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. (NCT02294396)
Timeframe: From first dose of study drug up to week 52

,,,
InterventionParticipants (Count of Participants)
Any TEAEsMildModerateSevereDrug-related TEAEsTEAEs leading to deathDrug-related TEAEs leading to deathSerious TEAEsDrug-related serious TEAEsTEAEs leading to withdrawal of treatmentDrug-related TEAEs leading to withdrawal of treat.
Mirabegron + Imidafenacin1331161527200501610
Mirabegron + Propiverine1351221308100411917
Mirabegron + Solifenacin13111315376001002312
Mirabegron + Tolterodine120104124741091188

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