Sacral Neuromodulation for Male Overactive Bladder
Axonics, Inc.
Summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Description
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Participants aged ≥ 18 years at the time of enrollment 2. Able to complete bladder diaries and patient questionnaires 3. Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)). 4. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year Key Exclusion Criteria: 1. Any patient that is not a suitable candidate per investigator discretion 2. Recent prostate therapy or procedure within the last 6 months…
Interventions
- DeviceAxonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Locations (20)
- University of Alabama at BirminghamBirmingham, Alabama
- Urology AssociatesFairhope, Alabama
- Mayo ClinicScottsdale, Arizona
- El Camino HealthMountain View, California
- Tri Valley UrologyMurrieta, California
- University of MiamiMiami, Florida