Objective of this study was confirmation on non-inferiority and validation of similar safety profile of new anti-muscarinic medicinal product Uritos® (Imidafenacin) in comparison with other product from m-cholinergic antagonists group Urotol® (Tolterodine).
To assess clinical efficiency and safety of Uritos® (Imidafenacin) in comparison to Urotol® (Tolterodine) according to its influence on urination frequency and number of urinary incontinence episodes a total of 327 patients underwent screening and 300 patients were randomized (150 patients in the Uritos® group and 150 patients in the Urotol® group). Screening period was not exceeding 2 weeks (14 days). Therapy was performed during 12 weeks (84 days). Every patient received only one treatment (Uritos® or Urotol®) during the treatment period. Patients were returning to the trial site to assessment visits on Weeks 2, 4, 8 and 12 with permissible variation ± 3 days. Observation period after the end of treatment - 30 ± 5 days (could be performed through telephone connection without need for physician appointment by patient). Maximum observation period: 136 days. Efficacy and safety parameters were assessed as per primary and secondary endpoints. The results of this study could potentially provide new optimum approaches to OAB treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Family polyclinic №4, LLC
Korolyov, Russia
A.I. Evdokimov Moscow State University of Medicine and Dentistry, Municipal Clinical Hospital named after Spasokukotskiy S.I
Moscow, Russia
N.I. Pirogov Russian National Research University
Moscow, Russia
Change in the Mean Daily Number of Urination Episodes at Week 12
The mean daily number of urination episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.
Time frame: Baseline and Week 12
Change in the Mean Daily Number of Incontinence Episodes at Week 12
The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.
Time frame: Baseline and Week 12
Change in the Mean Daytime Number of Incontinence Episodes at Week 12
The mean daytime number of incontinence episodes was calculated as the total number of episodes from 7 am to 11 pm for the study period (between visits) divided by the number of days in the period.
Time frame: Baseline and Week 12
Change in the Mean Nighttime Number of Incontinence Episodes at Week 12
The mean nighttime number of incontinence episodes was calculated as the total number of episodes from 11 pm to 7 am for the study period (between visits) divided by the number of days in the period.
Time frame: Baseline and Week 12
Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8
Separately for daily, daytime and nighttime measurements.
Time frame: Baseline and Week 2, 4 and 8
Change in the Mean Weekly Number of Incontinence Episodes at Week 12
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National Medical Radiological Center
Moscow, Russia
National N.I. Pirogov Medical and Surgical Center
Moscow, Russia
Rostov State Medical University
Rostov-on-Don, Russia
All-Russian A.M. Nikiforov Center for Emergency and Radiation Medicine
Saint Petersburg, Russia
Baltic Medicine LLC
Saint Petersburg, Russia
I.P. Pavlov First St. Petersburg State Medical University
Saint Petersburg, Russia
OrKli Hospital, LLC
Saint Petersburg, Russia
...and 1 more locations
The mean weekly number of incontinence episodes was calculated as the total number of episodes per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of weeks in the period.
Time frame: Baseline and Week 12
Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit
The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.
Time frame: Baseline and Week 2, 4 and 8
Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week
Overactive bladder (OAB) Awareness Tool Questionnaire (version OAB-V8, containing 8 questions) is a validated questionnaire. Patient is asked to answer 8 questions concerning typical symptoms of OAB giving answers with a scale with minimum - 0 score defined as "no bothering at all" and maximmum - 5 score defined as "a very big deal" to assess the severity of these symptoms. All answers are simply summed to make a combined final score. Male participants should add 2 points to their final score. The final scores range from 0 to 40 (for women) and 42 (for men). The score equal to 8 and more is interpreted as high probability of OAB presence, with the higher scores indicating more bothersome symptoms of OAB.
Time frame: Baseline and Week 2, 4, 8 and 12
Change in the EQ-5D-based Quality of Life at Week 12
The Euro Quality of Life five Dimensions questionnaire ( EQ-5D, version EQ-5D-5L) is a validated questionnaire for the assessment of health-related quality of life. It consists of a questionnaire and a visual analogue scale (EQ-VAS). The self-assessment questionnaire is self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to assess their own current level of function in each dimension by 5-level scale from "no problems" to "significant problem" grades. The EQ-VAS is a self-rated health status using a VAS in mm from 0 (the worse health status) to 100 (the best health status). The EQ-VAS records the subject's perceptions of their own current overall health quantitatively in mm and can be used to monitor changes with time. The results of patients assessment by VAS are presented.
Time frame: Baseline and Week 12