Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
This trial is active, not recruiting.
|Condition||refractory overactive bladder|
|Sponsor||Beijing Pins Medical Co., Ltd|
|Start date||October 2015|
|End date||November 2017|
|Trial size||7 participants|
|Trial identifier||NCT02619721, PINS-016|
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Sacral Neuromodulation is on as soon as implantation
Sacral Neuromodulation is off after implantation
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
time frame: 6 month of stimulation
Male or female participants at least 16 years old.
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
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