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

Completed

• Conditions: Overactive Bladder (OAB); Failed Any OAB Pharmacotherapy
• Interventions: Device: eTNM delivered by URIS I nerve stimulation device

• Registration Number: NCT05211193
• Lead Sponsor: Stimvia s.r.o.

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).

Study Timeline

• Study Start: 2020-01-08
• Primary Completion: 2020-04-28
• Study Completion: 2020-11-02
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
eTNM arm	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.

Primary Outcome Measures

Name	Time	Method
Change of severe urgency episodes	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.

Trial Locations

Locations (1)

MUDr. Michal Rejchrt; 🇨🇿 Příbram, Czech, Czechia