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

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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).

NCT05211193•Stimvia s.r.o.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (1)

MUDr. Michal Rejchrt

Příbram, Czech, Czechia

Key Dates

Start Date

January 8, 2020

Primary Completion Date

April 28, 2020

Completion Date

November 2, 2020

Last Updated

February 17, 2022

Enrollment

ACTUAL participants

Conditions

Overactive Bladder (OAB)Failed Any OAB Pharmacotherapy

Interventions

eTNM delivered by URIS I nerve stimulation device

DEVICE

INOPASE - Performance and Safety Study of a Personalised SNM System

NCT07193407

Overactive Bladder (OAB)

View study

RECRUITINGNA

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

NCT07195656

Overactive Bladder (OAB)

View study

ENROLLING_BY_INVITATIONNA

Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

NCT06765629

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

INOPASE - Performance and Safety Study of a Personalised SNM System

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.

Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial

BlueWind RENOVA iStim™ System for the Treatment of OAB