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

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).

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder (OAB); Failed Any OAB Pharmacotherapy
• Intervention / Treatment: Device: eTNM delivered by URIS I nerve stimulation device

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).

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Czechia
  • Czech
    • Příbram, Czech, Czechia, 261 01
      • MUDr. Michal Rejchrt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

females age 18 years or older. The women had a diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms. The women were dissatisfied with current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Stimvia s.r.o.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): April 28, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: TS003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No