Refractory Overactive BladderPhase 1NCT02946723
A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique
A Phase 1 study testing ultrasound and X-ray in people with Refractory Overactive Bladder, run by Beijing Pins Medical Co., Ltd.
Trial summary
Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical… 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?
- ultrasound and X-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Feb 2019
- Phase
- 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 > 16 years;
- Subjects suitable for SNM surgery;
- Normal upper urinary tract function;
- Bladder volume > 100 mL;
- Good compliance and able to complete the follow-up assessments.
Who cannot join
- Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke;
- Bladder lithiasis or tumor (cystoscopy or ultrasonography);
- Stress urinary incontinence;
- Bladder outlet obstruction;
- Diuresis > 3 liters per 24 hours;
- Negative at the test period or previous treatment with SNM;
- Pregnancy and plan to be pregnancy in 2 years.
Trial locations and contacts
No sites are listed yet.
Luming Li contact
About this study
Official title: A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB)With X-Ray Guided Technique
Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The device include IPG (implantable programme generator) and lead. In the initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This allows your doctors and you to assess your initial response according to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.
X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real time visual guidance ,easy to operate by doctors and a radiation free option to challenge anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and dedicating to developing better guidance technique in surgery.
The study here compare the efficacy and safety of ultrasound versus X ray guidance technique in SNM.
- Conditions
- Refractory Overactive Bladder
- Being tested
- ultrasound, X-ray
- 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.
ultrasoundProcedure or surgery
Lead implantation surgery for SNM using ultrasound guided technique
X-rayProcedure or surgery
Lead implantation surgery for SNM using X-ray technique
| Study group | Role | What they receive |
|---|---|---|
| US group | Experimental | lead implantation surgery for SNM using ultrasound guided technique Receives: Procedure: ultrasound |
| X-ray group | Sham comparator | lead implantation surgery for SNM using X-ray guided technique Receives: Procedure: X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate
Successful rate is the percentage of patients who experienced a successful result (≥50% improvements in baseline symptoms ) as recorded in voiding dairies.
Measured: 6 months post -IPG implantation
Secondary outcomes (5)
Adverse effect
Measured: During operation, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Guidance technique performance time
Measured: From beginning operation until successful lead placement is completed
Times of X-ray radiation
Measured: During operation
Overactive bladder symptom score (OABSS)
Measured: pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Quality of Life (QoL) scores
Measured: pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startFeb 2017
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946723
- Sponsor's protocol ID
- PINS-022
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB)With X-Ray Guided Technique
- ClinicalTrials.gov ID
- NCT02946723
- Acronym / sponsor ID
- PINS-022
- Conditions
- Refractory Overactive Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2017
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 27 Oct 2016 (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.
Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The device include IPG (implantable programme generator) and lead. In the initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This allows your doctors and you to assess your initial response according to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.
X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real time visual guidance ,easy to operate by doctors and a radiation free option to challenge anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and dedicating to developing better guidance technique in surgery.
The study here compare the efficacy and safety of ultrasound versus X ray guidance technique in SNM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US group | Experimental | Procedure: ultrasoundlead implantation surgery for SNM using ultrasound guided technique |
| X-ray group | Sham comparator | Procedure: X-raylead implantation surgery for SNM using X-ray guided technique |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 16 years;
- Subjects suitable for SNM surgery;
- Normal upper urinary tract function;
- Bladder volume > 100 mL;
- Good compliance and able to complete the follow-up assessments.
Key exclusion criteria (7 listed)
- Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke;
- Bladder lithiasis or tumor (cystoscopy or ultrasonography);
- Stress urinary incontinence;
- Bladder outlet obstruction;
- Diuresis > 3 liters per 24 hours;
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 |
|---|---|---|
| ultrasoundLead implantation surgery for SNM using ultrasound guided technique | Procedure or surgery | US group |
| X-rayLead implantation surgery for SNM using X-ray technique | Procedure or surgery | X-ray group |
Primary outcome
Successful rate
Time frame: 6 months post -IPG implantation
Successful rate is the percentage of patients who experienced a successful result (≥50% improvements in baseline symptoms ) as recorded in voiding dairies.
5 secondary outcomes
Adverse effect
Time frame: During operation, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Guidance technique performance time
Time frame: From beginning operation until successful lead placement is completed
Times of X-ray radiation
Time frame: During operation
Overactive bladder symptom score (OABSS)
Time frame: pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Quality of Life (QoL) scores
Time frame: pre-operation baseline, 2 weeks post-lead implantation, 3 and 6 months post -IPG implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
Luming Li contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ultrasound and X-ray in people with Refractory Overactive Bladder, run by Beijing Pins Medical Co., Ltd.
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 5 inclusion and 7 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Fumin Jia, PhD (010-59361265, pins_medical@163.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful rate (time frame: 6 months post -IPG implantation). 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 27 Oct 2016.