- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619721
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
October 8, 2016 updated by: Beijing Pins Medical Co., Ltd
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
7
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Beijing Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sacral Neuromodulation is on
Sacral Neuromodulation is on as soon as implantation
|
|
Placebo Comparator: Sacral Neuromodulation is off
Sacral Neuromodulation is off after implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
Time Frame: 6 month of stimulation
|
6 month of stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
November 1, 2017
Study Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
November 30, 2015
First Submitted That Met QC Criteria
November 30, 2015
First Posted (Estimate)
December 2, 2015
Study Record Updates
Last Update Posted (Estimate)
October 11, 2016
Last Update Submitted That Met QC Criteria
October 8, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PINS-016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractory Overactive Bladder
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Beijing Pins Medical Co., LtdUnknown
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University of OklahomaCompletedRefractory Overactive BladderUnited States
-
Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
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Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
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Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
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Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
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Merck Sharp & Dohme LLCTerminatedOveractive Bladder | Overactive Urinary Bladder
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