Overactive Bladder/Urinary Urgency Incontinence; Fecal Incontinence; or Non-obstructive Urinary Retention – Females and Males

Evaluation of InterStim Micro System Performance and Safety (ELITE) to confirm Long-term Outcomes

• A prospective, multi-center post-market study to confirm long-term clinical performance and safety of Medtronic’s implantable InterStim Micro System in males and females who are eligible and elect to have sacral neuromodulation therapy provided by this FDA-approved device (approved for clinical use in 2020). All eligible subjects have the InterStim Micro System implanted and are given active therapy per clinical standard of care.

Urinary Urgency Incontinence – Males and Females

Clinical Study of Neuspera’s Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Overactive Bladder

• A prospective, multi-center, pivotal clinical trial investigating the Neuspera implantable sacral nerve stimulation (SNS device) in male and female patients diagnosed with urinary urgency incontinence who have failed or could not tolerate more conservative treatments.  Phase I of the study is closed to enrollment but subjects are currently in long-term follow-up.  One of the principle objectives of Phase 1 was to provide data on the length of hours of daily stimulation needed to determine the duration of daily stimulation to be used in Phase 2 of the study.  The objective of Phase 2 is to assess the safety and efficacy of sacral nerve modulation provided by Neuspera’s implantable SNS device for the treatment of overactive bladder and urinary urgency incontinence.

Urinary Urgency Incontinence – Females

BlueWind RENOVA iStim™ for the Treatment of Overactive Bladder

• A multi-center, prospective, interventional, single arm study to demonstrate the safety and efficacy of the BlueWind RENOVA iStim™ in females for the treatment of urinary urgency incontinence alone or in combination with urinary urgency and/or urinary frequency. All subjects that are eligible for the study device are implanted with the investigational RENOVA iStim™ and given active therapy (no alternative or sham therapies).

Chronic Urinary Retention – Males 

Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter – Wireless Urinary Prosthesis for Management of Chronic Urinary Retention (FREEDOM Study)

• A multi-center, prospective, interventional, single-arm study to evaluate the safety and performance of UroDev Medical’s investigational Gen 2 Connected Catheter System in males who are dependent on catheter use because of insufficient bladder emptying (chronic urinary retention).  All subjects who are eligible for the study device are provided with device training and a new device on a weekly basis during the duration of their study participation.