Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).

Overactive Bladder (OAB) Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211193
• Other study ID #: TS003
• Status: Completed
• Start date: January 8, 2020
• Est. completion date: November 2, 2020

Study information

• Verified date: February 2022
• Source: Stimvia s.r.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Czechia	MUDr. Michal Rejchrt	Príbram	Czech

Sponsors (1)

Lead Sponsor	Collaborator
Stimvia s.r.o.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of severe urgency episodes	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.	baseline and end of study (6weeks treatment)