Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).

Stimvia s.r.o.1 site in 1 country40 target enrollmentJanuary 8, 2020

ConditionsOveractive Bladder (OAB)Failed Any OAB Pharmacotherapy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Overactive Bladder (OAB)
Sponsor: Stimvia s.r.o.
Enrollment: 40
Locations: 1
Primary Endpoint: Change of severe urgency episodes
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 8, 2020

End Date

November 2, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Stimvia s.r.o.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change of severe urgency episodes

Time Frame: 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.