Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
55 participants
INTERVENTIONAL
2025-09-18
2031-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Overactive Bladder
Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms.
Axonics SNM System INS Model 5101 (R20)
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
Interventions
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Axonics SNM System INS Model 5101 (R20)
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
Eligibility Criteria
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Inclusion Criteria
2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
Exclusion Criteria
2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
5. A female who is breastfeeding
6. A female with a positive urine pregnancy test
18 Years
ALL
No
Sponsors
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Axonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mahreen Pakzad, MD
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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University of Chicago
Chicago, Illinois, United States
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom
Pinderfields Hospital
Wakefield, West Yorkshire, United Kingdom
University College London Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Rowena Shi
Role: primary
Karen Regan
Role: primary
Stephen Cox
Role: backup
Toyin Familade
Role: primary
Nadia Malabi
Role: primary
Other Identifiers
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105-0104
Identifier Type: -
Identifier Source: org_study_id