Open-label, controlled, randomized, multicenter study to demonstrate the effect of the INKA digital therapy companion on symptoms of overactive bladder (with or without urinary incontinence). - C-23-413

Dr. Pfleger Arzneimittel GmbH0 个研究点目标入组 350 人开始时间: 2023年11月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Diagnosis of OAB with or without UI or mixed incontinence due to overactive bladder in combination with stress incontinence, when overactive bladder is the predominant symptom
•2.Averaged daily micturition frequency at randomization of = 8 micturitions/day, collected with a 3-day bladder protocol according to ICIQ
•3.Gender: male/female
•4.Age: 18 years or older
•5.Patients
•owho have been receiving stable pharmacologic treatment1 for the above indications for at least =4 weeks prior to screening or
•owho have not received (or have stopped receiving) pharmacological treatment1 for the named indications for = 4 weeks
•6.Ability to read and write German.
•7.Ownership and familiarity with a smartphone and ability to use it in daily life to respond to push messages, including regular use of mobile data away from home
•8.Informed consent for study participation and data processing.

•1.Regular, physiotherapy led pelvic floor muscle training in the last month (with or without app support)
•2.Pure stress incontinence without OAB
•3.Botulinum toxin treatment of the urinary bladder in the last 3 months
•4.Pregnancy or breastfeeding
•5.Lower urinary tract surgery with incomplete wound healing
•6.Hematuria
•7.Three or more urinary tract infections in the past 12 months
•8.Severe heart failure (= NYHA III) or renal insufficiency (eGFR <45 ml/min)
•9.Symptoms of overactive bladder resulting from previously diagnosed benign prostatic hyperplasia such as residual urine formation or condition after urinary retention
•10.Known malignant diseases of the genitourinary tract, e.g. bladder cancer, prostate cancer
•11.Neurological disease affecting the lower urinary tract (as judged by the investigator)
•12.Other circumstances or diagnoses that, in the judgment of the investigator, may critically affect the symptomatology of OAB and/or otherwise compromise the safety of the patient during the study or the validity of the data obtained from the study (e.g. recurrent urolithiasis, severe diarrhoea)
•13.Use of other apps with regard to bladder problems
•14.Participation in another clinical trial within one month prior to enrolment in this study
•15.Previous use of the INKA app
•16.Current or planned pessary treatment

发起方