BlueWind RENOVA iStim™ System for the Treatment of OAB

BlueWind Medical282 enrolled

Overview

The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

282

Conditions

Treatment of Patients Suffering From Overactive Bladder (OAB)

Interventions

RENOVA iStim™ SystemDEVICE

Tibial implantable neuromodulation device

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female aged 18 or greater (21 in the US) * More than or equal to 6 months history of UUI diagnosis * Patient who is mentally competent with the ability to understand and comply with the requirements of the study Exclusion Criteria: * Any significant medical condition that is likely to interfere with study procedures * Patients who are breastfeeding * Predominant stress incontinence * Have a life expectancy of less than 1 year * Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines

Locations (23)

University of California Irvine

Orange, California, United States

Outcomes

Primary Outcomes

≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes

Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.

Time frame: 6 months

Safety - Number of Participants With Adverse Events

The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).

Time frame: 12 months

Data from ClinicalTrials.gov

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