Imidafenacin for treatment of overactive bladder and urgent urinary incontinence: the results of open-label multicenter randomized controlled clinical trial


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Abstract

Introduction. The analysis of the results of a multicenter, open, randomized comparative phase III clinical trial on the use of imidafenacin for treating patients with OAB was carried out. A clinical study was conducted according to GCP standards in 12 urological centers of the Russian Federation with the support of company AO «R-Pharm». Materials and methods. A total of 296 patients (men and women) aged from 18 to 65 years with OAB and urgent urinary incontinence were included in the study. All patients were randomized into two groups. In Group 1 (n=148) patients received М-cholinoblocker imidafenacin 1 tablet (0,1 mg) twice a day. Group 2 patients (n=148) were prescribed a comparison drug tolterodine 1 tablet (2 mg) twice a day, as well. The duration of treatment was 12 weeks. Results. The analysis of results showed a significant decrease in the OAB symptoms in both groups. In Group 1 a decrease of episodes of urge urinary incontinence was more pronounce compared to Group 2, as well as amount of day-time and night-time of episodes of urge urinary incontinence by the 2nd, 4th, 8th and 12th weeks of treatment in comparison with baseline scores. There were no differences between two groups in the severity of reducing average urinary frequency per day. Reducing the severity of urinary disturbances in patients of both groups was accompanied by an improvement in the quality of life. There was a significant and similar decrease in the average total score of both OAB Awareness Tool and EQ-5D questionnaires. Tolerability of treatment was satisfactory in both groups and there were no differences in the adverse events in Group 1 and 2. Conclusion. Imidafenacin showed high clinical efficacy for treating patients with OAB, which is not inferior, and in some values, is superior in comparison to tolterodine. Both drugs had a similar safety and tolerability profile.

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About the authors

S. H Al-Shukri

FGBOU VO «Pavlov First Saint Petersburg State Medical University» of Minzdrav of Russia

Email: alshukri@mail.ru
Dr.Med.Sci., professor, Head of the Department of Urology

D. Yu Pushkar

A.I. Evdokimov Moscow State University of Medicine and Dentistry of Minzdrav of Russia

Email: pushkardm@mail.ru
corresponding member of RAS, Dr.Med.Sci., professor, Head of the Department of Urology

O. I Apolikhin

FGBU «The National Medical Research Radiologic Center» of Minzdrav of Russia

Email: apolikhin.oleg@gmail.com
corresponding member of RAS, Dr.Med.Sci., professor, Director

M. S Evdokimov

Family Policlinic №4 LLC

Email: 6733146@mail.ru
Cand.Med.Sci., urologist

M. I Kogan

FGBOU VO Rostov State Medical University of Minzdrav of Russia

Email: dept_kogan@mail.ru
Dr.Med.Sci., professor, Head of the Department of urology and reproductive health with the course of pediatric urology and andrology

G. G Krivoborodov

N.I. Pirogov RNRMU of Minzdrav of Russia

Email: dr.krivoborodov@yandex.ru
Dr.Med.Sci., professor at the Department ofUrology and Andrology

O. F Kagan

Hospital Orkli LTD

Email: ofkagan@mail.ru
Dr.Med.Sci., Professor, Head of the Department of Urology

S. B Petrov

FGBU «All-Russian Centre of Emergency and Radiation Medicine named after A.M. Nikiforov» of the Emergency of Russia

Email: petrov-uro@yandex.ru
Dr.Med.Sci., Professor, Head of the Department of Urology

A. N Poltoratskyi

Baltic Medicine LTD ООО

Email: 1.5artem@gmail.com
urologist

I. V Kuzmin

FGBOU VO «Pavlov First Saint Petersburg State Medical University» of Minzdrav of Russia

Email: kuzminigor@mail.ru
Dr.Med.Sci., Professor at the Department of Urology

G. G Sharvadze

AO «R-Farm»

Email: sharvadze@rpharm.ru
Ph.D., medical advisor of the Group of Medical support of the business in CIS countries /RF

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