E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Naive Subjects With Overactive Bladder (OAB) |
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E.1.1.1 | Medical condition in easily understood language |
Female Subjects with hyperactive overactive bladder |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective: • To examine the safety and tolerability of home-Based eTNM delivered by URIS I in subjects with OAB |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: • To examine the effect of eTNM on number, frequency and severity of urgency and urge incontinence episodes • To examine the effect of eTNM on the OAB-related quality of life
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Women 18 years or older, inclusive • Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms lasting for at least 6 months • No previous treatment of OAB except of pelvic floor muscle training and/or bladder training • Ability to understand and sign ICF • Subject agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests • Subject agrees not to participate in another study from the time of screening until the final study visit
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E.4 | Principal exclusion criteria |
• Subject has been previously treated for OAB symptoms by any method (including pharmacotherapy by anticholinergics and/or beta-3-mimetics, any kind of electrostimulation, intravesical injections of botulinum toxin etc.) except of pelvic floor muscle exercises and/or bladder training • Urinary retention with post-void residual > 150ml • Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; or symptomatic urinary tract infection (UTI) • Subject has exhibited history of diagnosed gastrointestinal obstructive disease • Subjects exhibiting clinically significant bladder outflow obstruction (BOO) • Subjects with history of severe hepatic impairment • Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: • Safety and tolerability based on all safety data collected in the study, including number and type of treatment emergent adverse events, and laboratory data.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints: • Proportion of subjects with ≥ 50% reduction in Urge Incontinence episodes after 12 weeks of therapy; • Change from baseline in mean PPIUS level of Urgency after 12 weeks of therapy.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
medical device IIa class - URIS I |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined by the Last visit of the Last Patient in TS002. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 10 |