Back to resultsClinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
Primary Purpose
Refractory Overactive Bladder
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
PINS SNS
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Overactive Bladder focused on measuring PINS SNS OAB
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
Sites / Locations
- Beijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sacral Neuromodulation is on
Sacral Neuromodulation is off
Arm Description
Sacral Neuromodulation is on as soon as implantation
Sacral Neuromodulation is off after implantation
Outcomes
Primary Outcome Measures
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
Secondary Outcome Measures
Full Information
NCT ID
NCT02619721
First Posted
November 30, 2015
Last Updated
October 8, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02619721
Brief Title
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Hospital
4. Oversight
5. Study Description
Brief Summary
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Overactive Bladder
Keywords
PINS SNS OAB
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacral Neuromodulation is on
Arm Type
Experimental
Arm Description
Sacral Neuromodulation is on as soon as implantation
Arm Title
Sacral Neuromodulation is off
Arm Type
Placebo Comparator
Arm Description
Sacral Neuromodulation is off after implantation
Intervention Type
Device
Intervention Name(s)
PINS SNS
Primary Outcome Measure Information:
Title
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
Time Frame
6 month of stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
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