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Clinical Trials/NCT02619721
NCT02619721
Unknown
Early Phase 1

Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)

Beijing Pins Medical Co., Ltd1 site in 1 country7 target enrollmentOctober 2015

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
February 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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