Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
NCT ID: NCT05211193
Last Updated: 2022-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2020-01-08
2020-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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eTNM arm
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.
eTNM 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.
Interventions
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eTNM 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Stimvia s.r.o.
INDUSTRY
Responsible Party
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Locations
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MUDr. Michal Rejchrt
Příbram, Czech, Czechia
Countries
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Other Identifiers
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TS003
Identifier Type: -
Identifier Source: org_study_id
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