NCT02619721
Unknown
Early Phase 1
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
ConditionsRefractory Overactive Bladder
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Refractory Overactive Bladder
- Sponsor
- Beijing Pins Medical Co., Ltd
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
- Last Updated
- 9 years ago
Overview
Brief Summary
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
Time Frame: 6 month of stimulation
Study Sites (1)
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