Neurogenic BladderCONTINENCENCT05301335
Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study
A study testing SCONE in people with Neurogenic Bladder and Spinal Cord Injuries (Complete and Incomplete), run by SpineX Inc. at 12 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurogenic Bladder, Spinal Cord Injuries (Complete and Incomplete), Stroke
- What is being tested?
- SCONE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 25 May 2022to 1 May 2024
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 and ≤ 70 years old (male subjects) or ≥ 18 and ≤ 75 years (female subjects) at the time of enrollment/consent.
- Subject has a diagnosis of NLUTD due to:
- Chronic, spinal cord injury at C3 to T8 classified as ASIA A-B on the AIS scale OR
- Chronic, spinal cord injury at C3 to L1 classified as ASIA C-D on the AIS scale OR
- Multiple sclerosis; OR
- Stroke
Show all 13Show fewer
- Subject has symptoms of urinary urgency (> 50% high urge voids) or increased frequency of micturition/self-catheterization (more than once every 2 hours) or incontinence between voids or catheterizations (> 5/day).
- Subject has sterile urine or asymptomatic bacteriuria.
- Subject's score is > 28 on NBSS survey.
- Subject is at least one year post initial diagnosis of NLUTD at the time of enrollment (consent).
- Subject's medical condition is stable.
- Subject has adequate social support network to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator.
- Subject has been informed of the nature of the study, can understand the requirements of the study, agrees to participate, and has signed the IRB/REB/EC-approved informed consent.
Who cannot join
- Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
- Subject has a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
- Subject has congestive heart failure, pulmonary disease necessitating supplemental oxygen use, chronic kidney disease (Stage III or higher), chronic liver disease (Child Pugh class B or C) or poorly controlled diabetes (if diabetic, HbA1c > 8.0 within the preceding 6 months).
- Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.
- Subject has an implanted central or peripheral neuromodulator.
- Subject has symptomatic, clinically significant autonomic dysreflexia attacks (characterized by headache and systolic blood pressure greater than 180 mmHg) more than once a week.
Show all 22Show fewer
- Subject is dependent on an electromagnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device.
- Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment.
- Subject's BMI is > 35.
- Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and /or bladder neck contracture).
- Subject has history of frequent symptomatic urinary tract infections, defined as receiving five or more courses of urinary tract infection directed antibiotics within 12 months prior to enrollment.
- For non catheterizing subjects, post void residual is > 100 mL measured by bladder ultrasound, bladder scanner, or one time catheterization at the time of enrollment
- For female subjects, history and/or screening responses consistent with pelvic organ prolapse.
- For non catheterizing male subjects older than 55 years of age, screening responses consistent with benign prostatic hyperplasia.
- Subjects with significant stress incontinence (> 3 stress incontinence episodes per day), defined as incontinence episodes during physical activity such as cough, sneeze, transfers, and other forms of physical activity.
- Subject is pregnant or trying to become pregnant; or is nursing.
- Subject has limited life expectancy or comorbid conditions, social/psychological problems, or cognitive impairments that, in the opinion of the Investigator, will preclude them from participation and completion of study procedures or requirements.
- Subject has a medical condition or complications related to the use of certain medications that may affect validity of the study as determined by the Investigator.
- Subject has a medical condition not listed above that may put the subject at risk as determined by the Investigator.
- Subject is participating in or plans to participate in another research study that may interfere with study endpoints.
- Subject is known or suspected to be non compliant; and/or subject is unable or unwilling to comply with study requirements.
- Subject was enrolled after the maximum number of targeted subjects were randomized into the respective disease or UUI group.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
Shepherd Centre
Atlanta, Georgia, 30309
Spaulding Rehabilitation Hospital Cambridge
Cambridge, Massachusetts, 02138
Atrium Health
Charlotte, North Carolina, 28208
Craig Hospital
Denver, Colorado, 80113
Rancho Research Institute
Downey, California, 90242
University of Miami, Desai Sehti Urology Institute
Miami, Florida, 33136
Columbia University Irving Medical Centre
New York, New York, 10032
Mayo Clinic, St. Mary's Campus
Rochester, Minnesota, 55902
UC San Diego Health Systems
San Diego, California, 92093
Medstar National Rehab
Washington D.C., District of Columbia, 20010
About this study
Official title: Spinal Cord Neuromodulator by SpineX and Scone to Treat Neurogenic Bladder
The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction
- Conditions
- Neurogenic Bladder, Spinal Cord Injuries (Complete and Incomplete), Stroke, Multiple Sclerosis
- Being tested
- SCONE
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries, Stroke, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCONEDevice
The Spinal COrd NEuromodulation(SCONE) device delivers a sufficient electrical signal non-invasively to activate the neural structures of the spinal cord without cutaneous discomfort. Rather than relying on stimulation of peripheral nerves, SCONE modulates the CNS directly via the spinal cord. Importantly, SCONE is a technique that enables electrical stimulation of the spinal cord without the need for insertion or implantation of stimulating electrodes
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Arm | Experimental | Not described Receives: Device: SCONE |
| Sham Arm | Sham comparator | Not described Receives: Device: SCONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurogenic Bladder Symptom Score (NBSS)
Lower score represents improvements
Measured: 12 weeks
Secondary outcomes (2)
Urge Urinary Incontinence Episodes
Lowered scores represents improvement
Measured: 12 weeks
Patient Global Improvement Index (PGI-I)
Lowered scores represents improvement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start25 May 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurogenic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a prospective, multicenter, single blind, two-arm randomized sham-controlled clinical study. Subjects will be randomized into a treatment arm and control (sham) arm in a 2:1 ratio.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpineX Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rancho Los Amigos National Rehabilitation Center, Downey, California, United States, Atrium Health, Charlotte, North Carolina, United States, MedStar National Rehabilitation Network, Washington, District of Columbia, United States, University of California, San Diego, Craig Hospital, Englewood, Colorado, United States, Columbia University, Institute of Brain and Spine (IBS Hospital), New Delhi, India, International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada, University of Miami, Miami, United States, Mayo Clinic, Rochester, Minnesota, United States, Shepherd Center, Atlanta GA, Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, United States
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301335
- Sponsor's protocol ID
- SPNX-001
- Acronym
- CONTINENCE
- Status last verified
- Nov 2024
- First submitted
- 19 Mar 2022
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kreydin EI, Abedi A, Morales L, Montero S, Kohli P, Ha N, Chapman D, Abedi A, Ginsberg D, Jann K, Harvey RL, Liu CY. Neural Mechanisms of Poststroke Urinary Incontinence: Results From an fMRI Study. Stroke. 2025 Jun;56(6):1516-1527. doi: 10.1161/STROKEAHA.124.048057. Epub 2025 Apr 10.
PubMed 40207355Ha NT, Abedi A, Ojeda LAM, Montero S, Kohli P, Chapman D, Abedi A, Gaburak P, Ginsberg D, Harvey RL, Liu CY, Jann K, Kreydin E. Using Functional Magnetic Resonance Imaging to Detect Differences in Micturition-Related Brain Activity Between Volitional and Involuntary Detrusor Contractions. Neurourol Urodyn. 2025 Feb;44(2):374-381. doi: 10.1002/nau.25655. Epub 2024 Dec 29.
PubMed 39737577
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Neuromodulator by SpineX and Scone to Treat Neurogenic Bladder
- ClinicalTrials.gov ID
- NCT05301335
- Acronym / sponsor ID
- CONTINENCE / SPNX-001
- Conditions
- Neurogenic Bladder, Spinal Cord Injuries (Complete and Incomplete), Stroke, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- SpineX Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rancho Los Amigos National Rehabilitation Center, Downey, California, United States, Atrium Health, Charlotte, North Carolina, United States, MedStar National Rehabilitation Network, Washington, District of Columbia, United States, University of California, San Diego, Craig Hospital, Englewood, Colorado, United States, Columbia University, Institute of Brain and Spine (IBS Hospital), New Delhi, India, International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada, University of Miami, Miami, United States, Mayo Clinic, Rochester, Minnesota, United States, Shepherd Center, Atlanta GA, Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, United States
- Study start
- 25 May 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 29 Mar 2022 (actual)
- 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.
The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is designed as a prospective, multicenter, single blind, two-arm randomized sham-controlled clinical study. Subjects will be randomized into a treatment arm and control (sham) arm in a 2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Arm | Experimental | Device: SCONE |
| Sham Arm | Sham comparator | Device: SCONE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is ≥ 18 and ≤ 70 years old (male subjects) or ≥ 18 and ≤ 75 years (female subjects) at the time of enrollment/consent.
- Subject has a diagnosis of NLUTD due to:
- Subject has symptoms of urinary urgency (> 50% high urge voids) or increased frequency of micturition/self-catheterization (more than once every 2 hours) or incontinence between voids or catheterizations (> 5/day).
- Subject has sterile urine or asymptomatic bacteriuria.
- Subject's score is > 28 on NBSS survey.
Key exclusion criteria (22 listed)
- Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
- Subject has a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
- Subject has congestive heart failure, pulmonary disease necessitating supplemental oxygen use, chronic kidney disease (Stage III or higher), chronic liver disease (Child Pugh class B or C) or poorly controlled diabetes (if diabetic, HbA1c > 8.0 within the preceding 6 months).
- Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.
- Subject has an implanted central or peripheral neuromodulator.
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 |
|---|---|---|
| SCONEThe Spinal COrd NEuromodulation(SCONE) device delivers a sufficient electrical signal non-invasively to activate the neural structures of the spinal cord without cutaneous discomfort. Rather than relying on stimulation of peripheral nerves, SCONE modulates the CNS directly via the spinal cord. Importantly, SCONE is a technique that enables electrical stimulation of the spinal cord without the need for insertion or implantation of stimulating electrodes | Device | Sham Arm, Therapeutic Arm |
Primary outcome
Neurogenic Bladder Symptom Score (NBSS)
Time frame: 12 weeks
Lower score represents improvements
2 secondary outcomes
Urge Urinary Incontinence Episodes
Time frame: 12 weeks
Patient Global Improvement Index (PGI-I)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 40207355Kreydin EI, Abedi A, Morales L, Montero S, Kohli P, Ha N, Chapman D, Abedi A, Ginsberg D, Jann K, Harvey RL, Liu CY. Neural Mechanisms of Poststroke Urinary Incontinence: Results From an fMRI Study. Stroke. 2025 Jun;56(6):1516-1527. doi: 10.1161/STROKEAHA.124.048057. Epub 2025 Apr 10.
- Derived from this study: PubMed 39737577Ha NT, Abedi A, Ojeda LAM, Montero S, Kohli P, Chapman D, Abedi A, Gaburak P, Ginsberg D, Harvey RL, Liu CY, Jann K, Kreydin E. Using Functional Magnetic Resonance Imaging to Detect Differences in Micturition-Related Brain Activity Between Volitional and Involuntary Detrusor Contractions. Neurourol Urodyn. 2025 Feb;44(2):374-381. doi: 10.1002/nau.25655. Epub 2024 Dec 29.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Bladder
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder
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.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCONE in people with Neurogenic Bladder and Spinal Cord Injuries (Complete and Incomplete), run by SpineX Inc. at 12 sites in 3 countries.
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 13 inclusion and 22 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: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, India. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurogenic Bladder Symptom Score (NBSS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301335, which also lists 2 linked publications.
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 17 Feb 2025.