Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Axonics, Inc.
Study ID
NCT06511141
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axonics SNM System — DEVICE
    To assess clinical outcomes of the Axonics SNM System in the male OAB population.

Study Details

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Key Dates

Start date
Oct 22, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Adverse event reporting (Safety) [ Time Frame: 6 months, 1 year ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205
Alisha Hitt
Adam Baumgarten, MD (PRINCIPAL_INVESTIGATOR)
Urology AssociatesFairhopeAlabama36532-
Mayo ClinicScottsdaleArizona85259
Sirena Castillo
Christopher Wolter, MD (PRINCIPAL_INVESTIGATOR)
El Camino HealthMountain ViewCalifornia94040
Annette West
Edward Karpman, MD (PRINCIPAL_INVESTIGATOR)
Tri Valley UrologyMurrietaCalifornia92562
Vivian Cabral Perez
Anita Deeds
Varun Talanki, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Maria N Odrosgoitia
Elena Cortizas
Raveen Syan, MD (PRINCIPAL_INVESTIGATOR)
Advanced Urology InstituteOxfordFlorida34481
Josi Cortese
Caitlyn Gall
Harvey Taub, MD (PRINCIPAL_INVESTIGATOR)
Louisiana State UniversityNew OrleansLouisiana70112
Jaya Mishra, PhD
Ryan Krlin, MD (PRINCIPAL_INVESTIGATOR)
WK Clinical ResearchShreveportLouisiana71103
Sherry Stephens
Gerard Henry, MD (PRINCIPAL_INVESTIGATOR)
Anne Arundel UrologyAnnapolisMaryland21401
Megan Lormore
Mara Holton, MD (PRINCIPAL_INVESTIGATOR)
Kari Bailey, MD (SUB_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Carter Day
Meghan Cooper, DO (PRINCIPAL_INVESTIGATOR)
Integrated Medical ProfessionalsNew YorkNew York10016
Michael Yang
Luis Leanez
Jed Kaminetsky, MD (PRINCIPAL_INVESTIGATOR)
Thomas Rechtschaffen, MD (SUB_INVESTIGATOR)
Associated Urologists of North Carolina (AUNC)RaleighNorth Carolina27612
Kiplyne Moffett, RN
Mark Jalkut, MD (PRINCIPAL_INVESTIGATOR)
John Kaspar, MD (SUB_INVESTIGATOR)
University Hospitals ClevelandClevelandOhio44106
Imani Lucas
Aram Loeb, MD (PRINCIPAL_INVESTIGATOR)
Utica Park UrologyTulsaOklahoma74104
Alex Heinze, PA-C
Melanie Ketchandji, MD (PRINCIPAL_INVESTIGATOR)
MidLantic UrologyBala-CynwydPennsylvania19004
Cheryl Zinar
Kelly Liberatore
Laurence Belkoff, DO (PRINCIPAL_INVESTIGATOR)
Lowcountry Urology ClinicsNorth CharlestonSouth Carolina29406
Madalyn Colbert
Shanteese La Mons
Justin Ellett, MD (PRINCIPAL_INVESTIGATOR)
Urology Partners of North Texas (UPNT)ArlingtonTexas76017-
Texas OncologyHoustonTexas77070-
Potomac UrologyWoodbridgeVirginia22191
Annelise Marsh
Alok Desai, MD (PRINCIPAL_INVESTIGATOR)

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