SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI (SCSBBD)

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.

Study Overview

• Status: Recruiting
• Conditions: SCI - Spinal Cord Injury; Bladder and Bowel Dysfunction
• Intervention / Treatment: Other: Spinal Cord Stimulation and Evaluation

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Lu, MD; Phone Number: +8656119530; Email: yanglu@btch.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tsinghua Chang Gung Hospital
    • Contact: Phone Number: +86 010-56112345; Email: office@btch.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Spinal Cord Stimulation; 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.

Other: Spinal Cord Stimulation and Evaluation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	Two weeks before the implant surgery, and 2, 4, 6 months after the surgery

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Principal Investigator: Yang Lu, Beijing Tsinghua Chang Gung

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Bladder and Bowel Dysfunction
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Digestive System Diseases; Gastrointestinal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Intestinal Diseases; Spinal Cord Injuries; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Spinal Cord Stimulation
• Other Study ID Numbers: 20241129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No