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BlueWind RENOVA iStim™ System for the Treatment of OAB

NCT03596671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2025-09-16

Study results available
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Summary

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.

Conditions

  • Treatment of Patients Suffering From Overactive Bladder (OAB)

Interventions

DEVICE

RENOVA iStim™ System

Tibial implantable neuromodulation device

Sponsors & Collaborators

  • BlueWind Medical

    lead INDUSTRY

Principal Investigators

  • John Heesakkers, MD · Maastricht University Medical Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2022-10-28
Completion
2025-01-24
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596671 on ClinicalTrials.gov