SAFETY AND EFFICACY OF VESUSTEN® FOR PATIENTS WITH OVERACTIVE BLADDER


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Abstract

Aim. To evaluate the efficiency and safety of Vesusten® (5 mg lyophilized powder for intramuscular injection in vial) compared to placebo in patients with overactive bladder (OAB). Materials and methods: a multicenter, double-blind, randomized, placebo-controlled III phase clinical trial was carried out in accordance with GCP guidelines (Good Clinical Practice). The study consisted of three stages: a screening period (lasting 14 days, after which Visit 1 was carried out), a period for evaluating the efficiency of therapy (duration 42±5 days; Visit 2 was at 21±5 days with an assessment of the patient's health status, as well as Visit 3 at the end of period for evaluating efficiency), the observation period (lasting 28±2 days and ending with Visit 4 to monitor the patient’s condition and assess the safety of therapy using a telephone survey by the researcher). Results: Vesusten® (5 mg) given 3 times a week intramuscularly resulted in pronounced effects: the average decrease in total of TUFS (Total Urgency and Frequency Score) was 1.97 times higher than in placebo group (p=0.0007), while the margin of superiority was 2.36 points (p=0.022). The daily number of urinary incontinence episodes decreased by 50% or more in 65.33% of patients compared to the baseline level (the difference with the placebo group was 24% by point estimates). The average number of urinary incontinence episodes in the group of Vesusten® decreased by 2.15 times compared to Placebo group. Vesusten® effects were more pronounced at Visit 3 (3 weeks after stopping therapy) compared to Visit 2 (3-weeks of therapy), which may indicate that Vesusten® (product containing bioactive peptides derived from the bladder) triggers a cascade interfering with OAB pathogenetic pathways followed by the bladder function restoration. Vesusten® has a favorable safety profile. There were no serious adverse events (SAE), and there were no significant differences between the Vesusten® and placebo groups in other safety parameters evaluated in this study. Conclusion. Our results suggest the favorable safety profile and the superiority of Vesusten® over placebo in terms of reducing OAB symptoms by TUFS (Total Urgency and Frequency Score) and reducing the number of incontinence episodes. A positive effect on patient’s quality of life was seen. Vesusten® is a promising effective and safe drug for the OAB treatment.

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About the authors

D. Yu Pushkar

A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of Russia

academician of RAS, professor, Ph.D., MD, Head of the Department of Urology, Chief urologist of the Ministry of Health of Russia Moscow, Russia

Y. A Kupriyanov

A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of Russia

Email: dr.kupriyanov@mail.ru
urologist, Ph.D., Deputy Chief Urologist of Moscow Health Department, associate professor at the Department of Urology, Moscow City Hospital named after S.I. Spasokukotsky Moscow, Russia

S. I Gamidov

National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakov of the Ministry of Health of Russia

Ph.D., MD, professor, Chief of the Department of Andrology and Urology Moscow, Russia

G. G Krivoborodov

Pirogov Russian National Research Medical University

Ph.D., MD, professor at the Department of Urology and Andrology Moscow, Russia

L. G Spivak

I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia; LLC «Family polyclinic No. 4»

Ph.D., MD, associate professor at the Institute of Urology and Human Reproductive Health, Chief of the Department of Clinical Trials of the Drugs and Diagnostic Tests of FGAOU VO I.M. Sechenov First Moscow State Medical University, Moscow, Russia, urologist at the Family Policlinic №4 LLC, c. Korolev, Moscow Region, Russia Moscow, Russia; Moscow region, Korolev, Russia

S. Kh Al-Shukri

FGBOU VO Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation; LLC «MK-Med»

Ph.D., MD, professor, Head of the Department of Urology Saint Petersburg, Russia

D. M Lerman

LLC «Chaika Clinics»

urologist, ultrasound sonographers Moscow, Russia

V. G Gomberg

GBUZ «City Geriatric Health Center»

Ph.D., Head of the Department of Urology Saint Petersburg, Russia

E. N Bogdan

LLC «Aurora Medi»

urologist Saint Petersburg, Russia

V. L Shchukin

LLC «Research Center Eco-safety»

urologist Saint Petersburg, Russia

K. H Chibirov

FSBI «SPb NIIF» of the Ministry of Health of Russia

urologist Saint Petersburg, Russia

V. V Gelashvili

FSBI «Clinical Hospital № 85 FMBA»

urologist, head of the Department of Clinical Trials Moscow, Russia

A. K Gural

OGBUZ «Medical and sanitary unit No. 2»

urologist Tomsk, Russia

N. G Keshishchev

FGBI «Joint Hospital and Polyclinic» Department of Presidential Affairs of the Russian Federation

Ph.D., urologist at the FGBI «Joint Hospital and Polyclinic» Department Moscow, Russia

M. A Staroselskaia

PEPTIDPRO LLC

medical advisor Moscow, Russia

N. A Bastrikova

PEPTIDPRO LLC

Ph.D. in Biology, medical director Moscow, Russia

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