Refractory Overactive Bladder
Conditions
Keywords
PINS SNS OAB
Brief summary
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
Interventions
DEVICEPINS SNS
Sponsors
Beijing Hospital
Beijing Pins Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation
Exclusion criteria
* Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month | 6 month of stimulation |
Countries
China
Outcome results
None listed