Failed Any OAB Pharmacotherapy, Overactive Bladder (OAB)
Conditions
Brief summary
Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.
Detailed description
Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).
Interventions
DEVICEeTNM delivered by URIS I nerve stimulation device
eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1-42.
Sponsors
Stimvia s.r.o.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women 18 years or older, inclusive * Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms * Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months * Treatment Satisfaction VAS \<50 * Ability to understand and sign ICF * Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests * Subject agreed not to participate in another research study from the time of screening until the final study visit * Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit
Exclusion criteria
* Prior treatment with botulotoxin for OAB * Previous pharmacotherapy for OAB if \>12 months ago * Urinary retention with post void residual \> 150ml * 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 * History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of severe urgency episodes | baseline and end of study (6weeks treatment) | The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation. |
Countries
Czechia
Outcome results
None listed