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Neuromodulation Device
Spinal Cord Stimulation for Bladder, Bowel, and Sexual Dysfunction
N/A
Recruiting
Led By Andrei Krassioukov, MD,PhD,FRCPC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 3-4, week 19, week 25
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a non-invasive treatment called TCSCS that uses electrical currents applied to the skin to help people with spinal cord injuries improve their bladder, bowel, and sexual functions. The goal is to offer a simpler and cheaper alternative to surgery. Electrical stimulation for bladder control has been explored as an alternative to traditional methods for treating neurogenic lower urinary tract dysfunction (NLUTD) resulting from spinal cord injury (SCI).
Who is the study for?
This trial is for adults aged 18-65 in British Columbia with chronic traumatic spinal cord injury above T6, complete motor paralysis, and documented bladder or sexual dysfunction. They must not be pregnant or planning pregnancy, agree to use contraception, have stable SCI management, no recent surgeries or infections that could interfere with the study, and sufficient hand function or caregiver support for catheterization.
What is being tested?
The trial tests Transcutaneous Spinal Cord Stimulation (TCSCS), a non-invasive method using skin-applied electrodes to improve bladder, bowel, and sexual function after spinal cord injury. It aims to offer an alternative to invasive implanted stimulators by exploring TCSCS's potential benefits without surgery.
What are the potential side effects?
While specific side effects of TCSCS are not detailed here, similar electrical stimulation treatments can sometimes cause discomfort at the electrode site, muscle twitching during stimulation sessions and may potentially alter blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 3-4, week 19, week 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 3-4, week 19, week 25
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in bladder capacity measured by urodynamics
Change in resting anorectal pressure determined via anorectal manometry
Secondary study objectives
Blood pressure will be measured continuously during TCSCS
Change in 24-hour blood pressure monitoring
Change in Autonomic Dysfunction following Spinal Cord Injury (ADFSCI) score
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: ModerateExperimental Treatment1 Intervention
Group 1: Moderate 2 times per week transcutaneous spinal cord stimulation.
Group II: IntensiveExperimental Treatment1 Intervention
Group 2: Intensive 5 times per week transcutaneous spinal cord stimulation.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Non-invasive electrical stimulation treatments, such as Transcutaneous Spinal Cord Stimulation (TCSCS), work by applying electrical currents through electrodes placed on the skin. These currents stimulate the nerves and muscles involved in bowel function, promoting motor and autonomic recovery.
This stimulation can enhance peristalsis, improve coordination of bowel movements, and increase the efficiency of the defecation process. For patients with Neurogenic Bowel, these treatments are crucial as they can significantly improve bowel control, reduce constipation and incontinence, and enhance overall quality of life without the need for invasive surgical procedures.
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Who is running the clinical trial?
International Collaboration on Repair DiscoveriesOTHER
7 Previous Clinical Trials
185 Total Patients Enrolled
Providence Health & ServicesOTHER
124 Previous Clinical Trials
823,747 Total Patients Enrolled
International Spinal Research TrustOTHER
5 Previous Clinical Trials
57 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,472 Previous Clinical Trials
2,489,580 Total Patients Enrolled
Andrei Krassioukov, MD,PhD,FRCPCPrincipal InvestigatorUniversity of British Columbia
6 Previous Clinical Trials
130 Total Patients Enrolled