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Catheterization performed by urology nurse, participant aware of time of procedure for Autonomic Dysreflexia

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 during screening

Awards & highlights

Study Summary

This trial looks at the effects of intermittent catheterization on physical and mental health in people with spinal cord injuries.

Who is the study for?

Adults aged 18-70 with chronic traumatic spinal cord injury, able to perform self-catheterization and complete questionnaires in English. Participants must be at least one year post-injury and six months from any spinal surgery. Excluded are those on the research team, with urinary tract issues or infections, history of bladder surgeries, taking heart rate affecting meds, pregnant women, or anyone with severe acute medical conditions.Check my eligibility

What is being tested?

The study compares how different catheterization methods affect anxiety and heart rate variability in individuals after a spinal cord injury. It tests self-catheterization versus nurse-performed procedures both when patients know and don't know the timing of the procedure.See study design

What are the potential side effects?

There may not be direct side effects from the interventions as they involve standard catheterization procedures; however, participants might experience discomfort or anxiety during the process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during self-catheterization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during self-catheterization

This trial's timeline: 3 weeks for screening, Varies for treatment, and during self-catheterization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BP during catheterization performed by urology nurse, participant aware of time of procedure

BP during catheterization performed by urology nurse, participant blinded to time of procedure

Blood pressure (BP) during self-catheterization

+6 more

Secondary outcome measures

Baseline trait anxiety

Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure

Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Individuals with motor-incomplete SCIExperimental Treatment3 Interventions

Individuals with motor sensory incomplete injury (AIS C/D)

Group II: Individuals with motor-complete SCIExperimental Treatment3 Interventions

Individuals with motor sensory complete injury (AIS A/B)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

International Collaboration on Repair DiscoveriesUNKNOWN

7 Previous Clinical Trials

205 Total Patients Enrolled

3 Trials studying Autonomic Dysreflexia

116 Patients Enrolled for Autonomic Dysreflexia

University of British ColumbiaLead Sponsor

1,422 Previous Clinical Trials

2,468,353 Total Patients Enrolled

4 Trials studying Autonomic Dysreflexia

103 Patients Enrolled for Autonomic Dysreflexia

ConvaTec Inc.Industry Sponsor

47 Previous Clinical Trials

4,911 Total Patients Enrolled

Frequently Asked Questions

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

Are there still available slots for participants in this clinical research?

"The relevant clinicaltrials.gov website reveals that the trial in question is not currently accepting participants, despite its initial posting on December 1st 2022 and subsequent alteration on November 4th of the same year. Nevertheless, there are 794 other medical trials actively seeking volunteers at this moment."

Answered by AI

Does my profile match the criteria required to join this research project?

"This medical experiment is enrolling twenty individuals, aged between 18 and 70 years old who have neurogenic urinary bladder. Participants need to be male or female, must have experienced their injury at least 12 months prior, should not have gone through spinal surgery for a minimum of 6 months preceding the trial and require sufficient motor function in order to carry out intermittent catheterization. In addition, they will need to comprehend English or employ an interpreter that's approved by the investigator; possess a chronic traumatic SCI with either sensory-motor complete (AIS A/B) or incomplete injury (AIS B/D); provide informed consent and exhibit"

Answered by AI

Are individuals younger than 70 years of age able to participate in this research?

"This trial is open to individuals aged between 18 and 70 years old. Alternatively, 162 trials are dedicated to those under the age of 18 whilst 598 studies cater for patients who have passed their 65th birthday."

Answered by AI

What are the key goals of this medical trial?

"The primary outcome of this medical trial, to be evaluated over the duration of self-catheterization, is heart rate. Secondary outcomes include a Change in State Anxiety (STAIS-5) during self-catheterization - where scores between 5 and 20 denote increasing levels of anxiety - as well as a Change in State Anxiety when catheterized by an experienced urologist with the participant being blinded or aware to the time period respectively (GA-VAS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

Andrei Krassioukov 2022. "Heart Rate Variability and Anxiety During Urinary Bladder Catheterization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05380661.

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