Status:
COMPLETED
Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
Lead Sponsor:
Stimvia s.r.o.
Conditions:
Overactive Bladder (OAB)
Failed Any OAB Pharmacotherapy
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05211193
Start Date
January 8 2020
End Date
November 2 2020
Last Update
February 17 2022
Active Locations (1)
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1
MUDr. Michal Rejchrt
Příbram, Czech, Czechia, 261 01