Benign Prostatic Hyperplasia, Overactive Bladder, Prostate Cancer, Prostatectomy, Urinary Frequency, Urinary Urgency Incontinence
Conditions
Brief summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Detailed 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).
Interventions
DEVICEAxonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Sponsors
Axonics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 at the time of enrollment 3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia) 4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices 5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS) 6. Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment 7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician 8. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives at the discretion of the participating physician. 9. Uncontrolled diabetes 10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event reporting (Safety) | 6 months, 1 year | Device related, procedure-related and all serious adverse events |
| Performance/Effectiveness - Reduction in UUI or UF episodes | 6 months, 1 year | Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance/Effectiveness - Improvement in Quality of Life scoring | 6 months, 1 year | International Consultation of Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement. |
Countries
United States
Contacts
CONTACTCatherine Cabiling
CONTACTErum Shaikh
STUDY_DIRECTORGita Ghadimi, OD
Boston Scientific Corporation
Outcome results
None listed