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

NCT05211193 | Completed

• 1 other identifier: TS003
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder (OAB); Failed Any OAB Pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

eTNM delivered by URIS I nerve stimulation device 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.

eTNM arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stimvia s.r.o.: lead

Study Sites (1)

MUDr. Michal Rejchrt

Příbram, Czech, 261 01, Czechia

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: January 8, 2020
• Primary Completion: April 28, 2020
• Study Completion: November 2, 2020
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)