Sacral Neuromodulation for Male Overactive Bladder
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants aged ≥ 18 years at the time of enrollment
• Able to complete bladder diaries and patient questionnaires
• Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Urology Associates
RECRUITING
Fairhope
California
El Camino Health
RECRUITING
Mountain View
Tri Valley Urology
RECRUITING
Murrieta
Florida
University of Miami
RECRUITING
Miami
Louisiana
Louisiana State University
RECRUITING
New Orleans
WK Clinical Research
RECRUITING
Shreveport
Minnesota
Mayo Clinic
RECRUITING
Rochester
Ohio
University Hospitals Cleveland
RECRUITING
Cleveland
Oklahoma
Utica Park Urology
RECRUITING
Tulsa
Texas
Urology Partners of North Texas (UPNT)
RECRUITING
Arlington
Texas Oncology
RECRUITING
Houston
Virginia
Potomac Urology
RECRUITING
Woodbridge
Contact Information
Primary
Gita Ghadimi, OD
Gita.Ghadimi@bsci.com
949-396-6322
Backup
Erum Shaikh
Erum.Shaikh@bsci.com
949-396-6322
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2028-03
Participants
Target number of participants: 150
Treatments
Other: Post-prostatectomy
History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment
Other: Radiation
History of radiation for cancer treatment at least 6 months prior to enrollment
Other: Benign Prostatic Hyperplasia (BPH)
History of cytoreductive BPH surgery at least 6 months prior to enrollment
Related Therapeutic Areas
Sponsors
Leads: Axonics, Inc.