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

Stimvia

Status: Completed

Conditions: Failed Any OAB Pharmacotherapy; Overactive Bladder (OAB)

Treatments: Device: eTNM delivered by URIS I nerve stimulation device

Study type: Observational

Funder types: Industry

Identifiers

NCT05211193

TS003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

40 participants in 1 patient group

eTNM arm

Description:

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.

Treatment:

Device: eTNM delivered by URIS I nerve stimulation device