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NCT Number: NCT07511244

SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Spinal Cord Stimulation and Evaluation

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. The Wexner Anorectal Incontinence Scale

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  2. Elimination Journal

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  3. Gastrointestinal Emptying Study

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  4. Defecography

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  5. Anorectal Manometry

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  6. Urodynamic Study

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  7. 36-Item Short Form Health Survey,SF-36

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  8. 10-Meter Walk Test (10MWT)

    Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

    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.

  9. 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

    Measures walking in people with spinal cord injury, by the amount of physical assistance, braces or devices required to walk 10 meters.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Lu, MD

CONTACT

[email protected]

+8656119530

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Clinical Trial on the Safety and Efficacy of Spinal Cord Stimulation Therapy for Patients With Bladder and Bowel Dysfunction After Spinal Cord Injury

Acronym: SCSBBD

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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