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Neuromodulation Device

Moderate for Neurogenic Bowel

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

Study Summary

This trial will test a new, non-invasive way of stimulating the spinal cord to see if it can help people with spinal cord injuries recover bladder, bowel, and sexual function.

Eligible Conditions
  • Neurogenic Bowel
  • Neurogenic Bladder
  • Spinal Cord Injury
  • Spinal Cord Stimulation
  • Sexual Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 3-4, week 19, week 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 3-4, week 19, week 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in bladder capacity measured by urodynamics
Change in resting anorectal pressure determined via anorectal manometry
Secondary outcome measures
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 more

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.

Find a Location

Who is running the clinical trial?

International Collaboration on Repair DiscoveriesOTHER
7 Previous Clinical Trials
185 Total Patients Enrolled
Providence Health & ServicesOTHER
117 Previous Clinical Trials
822,495 Total Patients Enrolled
International Spinal Research TrustOTHER
5 Previous Clinical Trials
70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the expected results of this research?

"This study will assess the efficacy of anorectal manometry over a 4-6 week and 19th week period. Secondary measures include Surface EMG recording with TCSCS, changes to International Standards for Neurological Classification of Spinal cord injury (ISNCSCI) scores, and alterations to Neurogenic Bladder Symptom Scores (NBSS)."

Answered by AI

How many individuals are currently being monitored in this research endeavor?

"Confirmed. According to clinicaltrials.gov, this medical trial is enlisting patients even as we speak; the original post dating back to May 2nd 2022 and its most recent update being November 25th of that same year. The investigation requires 40 participants from two different clinics."

Answered by AI

Is the enrollment period currently open for this investigative study?

"Confirmed - this medical investigation, initially posted on May 2nd 2022 according to clinicaltrials.gov, is actively recruiting patients. The associated details were last revised November 25th of the same year."

Answered by AI

May I be granted access to participate in this medical study?

"This clinical trial is seeking 40 willing participants aged between 18 and 65 that have been diagnosed with neurogenic bowel. Furthermore, they must be male or female, possess the capacity to perform Clean Intermittent Catheterization (CIC) by themselves or through a caregiver's assistance; also three days of bladder and bowel history need to precede their baseline visit. Additionally, greater than antigravity strength in deltoids and biceps needs to exist bilaterally for at least one year since injury as well as six months following any spinal surgery. Lastly, documented evidence of either sexual dysfunction or bowels dysfunction should be present."

Answered by AI

Does this research seek to include geriatric participants?

"Patients between the ages of 18 and 65 are admissible for this clinical trial, while those younger or older than that will have to seek out other trials; there are 151 studies available for people under 18, and 755 for seniors."

Answered by AI
~14 spots leftby Apr 2025