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New treatment option for Bladder and Bowel Dysfunction
Official title SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI
ClinicalTrials.gov ID: NCT07511244
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.