Bladder and Bowel DysfunctionSCSBBDNCT07511244
SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI
A study testing Spinal Cord Stimulation and Evaluation in people with Bladder and Bowel Dysfunction and SCI - Spinal Cord Injury, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the safety and efficacy of spinal cord stimulation (SCS) in treating patients with urinary and bowel dysfunction after spinal cord injury (SCI). SCI is a highly disabling condition that can lead to sensory, motor, and autonomic nervous system dysfunction below the injury level. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bladder and Bowel Dysfunction, SCI - Spinal Cord Injury
- What is being tested?
- Spinal Cord Stimulation and Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 60 years old
- Spinal Cord Injury Classification: AIS Grade A, B, C, or D
- Injury Duration: > 6 months
- Stable and healthy condition, as determined by the investigator; able to complete the entire study period and cooperate with examinations
- Voluntary participation in clinical trial and ability to sign informed consent form
- Good patient compliance, willing and able to follow follow-up requirements during the follow-up period
Who cannot join
- Mental Disorders Patients with obvious mental illnesses (such as anxiety, depression, etc.) who are unable to complete relevant subjective scoring.
- Mental and Cognitive Impairments Patients with mental or cognitive disorders who are unable to cooperate with surgeries, undergo programming procedures, or complete follow - up.
- Autonomic Reflex Disorders Patients with severe autonomic reflex disorders.
- Inability in Surgical and Follow - up Processes Patients who are unable to undergo spinal cord stimulation surgery or cooperate with follow - up.
- Spinal Abnormalities Patients accompanied by progressive spinal instability or severe spinal deformities.
- Life Expectancy Patients with an expected lifespan of less than one year.
Show all 12Show fewer
- Laboratory Abnormalities and Surgical Tolerance Patients with abnormal blood routine, blood biochemistry, etc., and are clinically judged to be unable to tolerate surgery, such as those with coagulation disorders, abnormal liver and kidney function.
- Cardiovascular and Respiratory Diseases Patients with uncontrolled hypertension, severe heart diseases, or severe internal medicine and respiratory system diseases, or those who have regularly taken medications related to hypertension and heart diseases within the recent three months.
- Renal Disorders Patients with severe hydronephrosis or renal function disorders.
- Urogenital Function Disorders before Spinal Cord Injury Patients with pre - existing urethral sphincter or bladder dysfunction before spinal cord injury.
- History of Pelvic Surgery and Radiotherapy Patients with a history of pelvic radiotherapy, bladder cancer, or other bladder surgeries that affect the basic bladder physiology.
- Other Inappropriate Cases Patients considered inappropriate by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing
010-56112345 ext. +86, office@btch.edu.cn
About this study
Official title: Clinical Trial on the Safety and Efficacy of Spinal Cord Stimulation Therapy for Patients With Bladder and Bowel Dysfunction After Spinal Cord Injury
This clinical trial aims to evaluate the safety and efficacy of spinal cord stimulation (SCS) in treating patients with urinary and bowel dysfunction after spinal cord injury (SCI). SCI is a highly disabling condition that can lead to sensory, motor, and autonomic nervous system dysfunction below the injury level. Neurogenic bladder and bowel dysfunction are common sequelae of SCI, seriously affecting patients' quality of life. Currently, clinical treatments can only partially alleviate urinary and bowel dysfunction, and more effective therapeutic approaches are still needed. Existing clinical studies have shown that SCS is gradually being applied to treat neurogenic bladder and bowel dysfunction in SCI patients. SCS can significantly improve urinary efficiency, bladder capacity, compliance, and detrusor pressure in SCI patients, thereby enhancing their quality of life. The main questions this study aims to answer include: 1. Can this protocol help patients restore partial urinary and bowel function? 2. Besides the restoration of partial urinary and bowel function , can the SCS therapy could also help patients to restore the walking function.
Patients with urinary and bowel dysfunction more than 6 months after spinal cord injury will undergo epidural spinal stimulation electrode implantation surgery two weeks after functional assessment. Then the parameter optimization and rehabilitation will last for 6 months. The follow-up records and assessments will be conducted monthly at 2, 4, and 6 months after surgery.
- Being tested
- Spinal Cord Stimulation and Evaluation
- Keywords
- Bladder and Bowel Dysfunction, Spinal Cord Injury
- Medical subject headings
- Intestinal Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation and EvaluationOther
Patients with dysuria and defecation disorders due to spinal cord injury lasting over 6 months should undergo subdural spinal cord stimulation electrode implantation surgery two weeks after functional assessment. Device adjustment and parameter confirmation should be conducted four weeks after surgery. Follow-up assessments and examinations should be conducted monthly at 2, 4, and 6 months post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Participants will receive pre-implantation rehabilitation, evaluation, implantation of the spinal cord stimulator, and stimulation (according to the functional mapping) assisted rehabilitation post-implantation during the trial. Receives: Other: Spinal Cord Stimulation and Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurogenic Bowel Dysfunction, NBD
This is a clinical symptom assessment scale for colorectal and anal dysfunction in patients with spinal cord injury. It consists of 10 items, including defecation frequency, defecation time, accompanying symptoms, medication status, etc. The maximum score is 47 points, and a score above 14 points indicates severe intestinal dysfunction.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Neurogenic Bladder Symptom Score, NBSS
Including three dimensions: urinary incontinence (8 items), urine storage and voiding (7 items), and outcomes (7 items), with a total of 24 items. Two items are non-scoring items. The first item is categorized based on the patient's bladder management method, and the last item is an overall quality of life assessment to evaluate the patient's voiding pattern and quality of life. Each item is scored from 0 to 3 points or 0 to 4 points. The total score of the scale is 74 points, with higher scores indicating more significant neurogenic bladder symptoms.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Secondary outcomes (9)
The Wexner Anorectal Incontinence Scale
It is a scale used to assess the severity of bowel movements in patients, applicable to patients with fecal incontinence caused by various reasons. The scale consists of 5 items, with a scoring range of 0-20 points. A higher score indicates a more severe degree of incontinence.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Elimination Journal
A voiding diary is a semi-objective examination method. It is recommended to record for 2-3 days or more to obtain reliable results. This examination is non-invasive and reproducible, making it a recommended urinary system assessment for patients with spinal cord injury. The defecation diary includes information such as stool characteristics, frequency of defecation, defecation time, complete emptying sensation, difficulty in defecation, dietary conditions, and methods of assisted defecation. It is widely used in the assessment of diseases accompanied by defecation dysfunction.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Gastrointestinal Emptying Study
It is a first-line diagnostic method for gastric motility function. Patients need to orally ingest a certain amount of barium sulfate, and then the gastric emptying situation is observed to determine whether the peristaltic function of the gastrointestinal tract is normal.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Defecography
This is an examination method that involves injecting a contrast agent with the same volume and viscosity as normal feces into the rectum, and observing the morphological and functional changes of the anal canal and rectum during sitting, anal lifting, forceful defecation, and after fecal emptying. It belongs to dynamic X-ray imaging technology and is used to understand the defecation process.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Anorectal Manometry
This method involves placing a pressure measurement device into the rectum to measure the contraction and relaxation of the anus, examining the function and coordination of both the internal and external sphincters, pelvic floor, and rectum. It provides objective indicators for evaluating the anal canal and rectal sphincter function.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Urodynamic Study
One hour before the examination, please have the patient drink 500ml of water. Once the bladder is full and the patient feels the urge to urinate, proceed with the examination to measure the patient's urine flow rate and residual urine volume.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
36-Item Short Form Health Survey，SF-36
Including 36 items divided into 8 dimensions: physiological function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These dimensions fall under two major categories: physical health and mental health. The final score for each dimension ranges from 0 (lowest) to 100 (highest), with higher scores indicating better quality of life.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
10-Meter Walk Test (10MWT)
assesses gait speed by timing a patient walking over a 10-meter (32.8 feet) distance, often measuring the central 6 meters to exclude acceleration/deceleration. It calculates speed in meters per second (m/s) to evaluate functional mobility, commonly for stroke or neurological conditions.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Walking Index for Spinal Cord Injury II (WISCI II)
Measures walking in people with spinal cord injury, by the amount of physical assistance, braces or devices required to walk 10 meters.
Measured: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder and Bowel DysfunctionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Lu, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Yang Lu, Principal investigator, Beijing Tsinghua Chang Gung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511244
- Sponsor's protocol ID
- 20241129
- Acronym
- SCSBBD
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang X, Lu Y, Zhang B, Li H, Yao Q, Lim J, Wei Y, He K, Zuo C, Sui Y, Ma B, Ran M, Pan Y, Wang G, Li L. Voluntary walking related joint movement training with targeted epidural electrical stimulation enabled neural recovery for individuals with spinal cord injury. Sci Bull (Beijing). 2024 Nov 30;69(22):3507-3511. doi: 10.1016/j.scib.2024.09.036. Epub 2024 Sep 26. No abstract available.
PubMed 39366832
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Safety and Efficacy of Spinal Cord Stimulation Therapy for Patients With Bladder and Bowel Dysfunction After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07511244
- Acronym / sponsor ID
- SCSBBD / 20241129
- Keywords
- Bladder and Bowel Dysfunction, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Apr 2026 (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.
This clinical trial aims to evaluate the safety and efficacy of spinal cord stimulation (SCS) in treating patients with urinary and bowel dysfunction after spinal cord injury (SCI). SCI is a highly disabling condition that can lead to sensory, motor, and autonomic nervous system dysfunction below the injury level. Neurogenic bladder and bowel dysfunction are common sequelae of SCI, seriously affecting patients' quality of life. Currently, clinical treatments can only partially alleviate urinary and bowel dysfunction, and more effective therapeutic approaches are still needed. Existing clinical studies have shown that SCS is gradually being applied to treat neurogenic bladder and bowel dysfunction in SCI patients. SCS can significantly improve urinary efficiency, bladder capacity, compliance, and detrusor pressure in SCI patients, thereby enhancing their quality of life. The main questions this study aims to answer include: 1. Can this protocol help patients restore partial urinary and bowel function? 2. Besides the restoration of partial urinary and bowel function , can the SCS therapy could also help patients to restore the walking function.
Patients with urinary and bowel dysfunction more than 6 months after spinal cord injury will undergo epidural spinal stimulation electrode implantation surgery two weeks after functional assessment. Then the parameter optimization and rehabilitation will last for 6 months. The follow-up records and assessments will be conducted monthly at 2, 4, and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Other: Spinal Cord Stimulation and EvaluationParticipants will receive pre-implantation rehabilitation, evaluation, implantation of the spinal cord stimulator, and stimulation (according to the functional mapping) assisted rehabilitation post-implantation during the trial. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18 to 60 years old
- Spinal Cord Injury Classification: AIS Grade A, B, C, or D
- Injury Duration: > 6 months
- Stable and healthy condition, as determined by the investigator; able to complete the entire study period and cooperate with examinations
- Voluntary participation in clinical trial and ability to sign informed consent form
Key exclusion criteria (12 listed)
- Mental Disorders Patients with obvious mental illnesses (such as anxiety, depression, etc.) who are unable to complete relevant subjective scoring.
- Mental and Cognitive Impairments Patients with mental or cognitive disorders who are unable to cooperate with surgeries, undergo programming procedures, or complete follow - up.
- Autonomic Reflex Disorders Patients with severe autonomic reflex disorders.
- Inability in Surgical and Follow - up Processes Patients who are unable to undergo spinal cord stimulation surgery or cooperate with follow - up.
- Spinal Abnormalities Patients accompanied by progressive spinal instability or severe spinal deformities.
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 |
|---|---|---|
| Spinal Cord Stimulation and EvaluationPatients with dysuria and defecation disorders due to spinal cord injury lasting over 6 months should undergo subdural spinal cord stimulation electrode implantation surgery two weeks after functional assessment. Device adjustment and parameter confirmation should be conducted four weeks after surgery. Follow-up assessments and examinations should be conducted monthly at 2, 4, and 6 months post-surgery. | Other | Spinal Cord Stimulation |
Primary outcome
Neurogenic Bowel Dysfunction, NBD
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
This is a clinical symptom assessment scale for colorectal and anal dysfunction in patients with spinal cord injury. It consists of 10 items, including defecation frequency, defecation time, accompanying symptoms, medication status, etc. The maximum score is 47 points, and a score above 14 points indicates severe intestinal dysfunction.
Neurogenic Bladder Symptom Score, NBSS
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Including three dimensions: urinary incontinence (8 items), urine storage and voiding (7 items), and outcomes (7 items), with a total of 24 items. Two items are non-scoring items. The first item is categorized based on the patient's bladder management method, and the last item is an overall quality of life assessment to evaluate the patient's voiding pattern and quality of life. Each item is scored from 0 to 3 points or 0 to 4 points. The total score of the scale is 74 points, with higher scores indicating more significant neurogenic bladder symptoms.
9 secondary outcomes
The Wexner Anorectal Incontinence Scale
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Elimination Journal
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Gastrointestinal Emptying Study
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Defecography
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Anorectal Manometry
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Urodynamic Study
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
36-Item Short Form Health Survey，SF-36
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
10-Meter Walk Test (10MWT)
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 39366832Zhang X, Lu Y, Zhang B, Li H, Yao Q, Lim J, Wei Y, He K, Zuo C, Sui Y, Ma B, Ran M, Pan Y, Wang G, Li L. Voluntary walking related joint movement training with targeted epidural electrical stimulation enabled neural recovery for individuals with spinal cord injury. Sci Bull (Beijing). 2024 Nov 30;69(22):3507-3511. doi: 10.1016/j.scib.2024.09.036. Epub 2024 Sep 26. No abstract available.
- Individual participant dataSharing planned: No
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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.
Yang Lu principal investigator
Beijing Tsinghua Chang Gung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation and Evaluation in people with Bladder and Bowel Dysfunction and SCI - Spinal Cord Injury, run by Beijing Tsinghua Chang Gung Hospital 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Lu, MD (+8656119530, yanglu@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurogenic Bowel Dysfunction, NBD (time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery). The study lists 2 primary outcomes in all. 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 NCT07511244, which also lists 1 linked publication.
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 6 Apr 2026.