Refractory Overactive BladderEarly Phase 1NCT02619721
Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
A Early Phase 1 study testing PINS SNS in people with Refractory Overactive Bladder, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial summary
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Refractory Overactive Bladder
- What is being tested?
- PINS SNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Feb 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
- Conditions
- Refractory Overactive Bladder
- Being tested
- PINS SNS
- Keywords
- PINS SNS OAB
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINS SNSDevice
| Study group | Role | What they receive |
|---|---|---|
| Sacral Neuromodulation is on | Experimental | Sacral Neuromodulation is on as soon as implantation Receives: Device: PINS SNS |
| Sacral Neuromodulation is off | Placebo comparator | Sacral Neuromodulation is off after implantation Receives: Device: PINS SNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
Measured: 6 month of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619721
- Sponsor's protocol ID
- PINS-016
- Status last verified
- Mar 2016
- First submitted
- 30 Nov 2015
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT02619721
- Acronym / sponsor ID
- PINS-016
- Conditions
- Refractory Overactive Bladder
- Keywords
- PINS SNS OAB
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Hospital
- Study start
- Oct 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacral Neuromodulation is on | Experimental | Device: PINS SNSSacral Neuromodulation is on as soon as implantation |
| Sacral Neuromodulation is off | Placebo comparator | Device: PINS SNSSacral Neuromodulation is off after implantation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PINS SNS | Device | Sacral Neuromodulation is off, Sacral Neuromodulation is on |
Primary outcome
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
Time frame: 6 month of stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PINS SNS in people with Refractory Overactive Bladder, run by Beijing Pins Medical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month (time frame: 6 month of stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.