Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000869875
Ethics application status
Approved
Date submitted
5/05/2021
Date registered
6/07/2021
Date last updated
12/12/2022
Date data sharing statement initially provided
6/07/2021
Date results provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Bladder Neuromodulation for Chronic Spinal Cord Injury
Scientific title
Safety, feasibility, and compliance of home use of transcutaneous electrical nerve stimulation (TENS) for bladder dysfunction in chronic spinal cord injury: a pilot translational study
Secondary ID [1] 304140 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 321834 0
Neurogenic bladder 321835 0
Overactive bladder 321836 0
Urinary incontinence 322177 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319564 319564 0 0
Other physical medicine / rehabilitation
Neurological 319863 319863 0 0
Other neurological disorders
Renal and Urogenital 319864 319864 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- All participants will receive transcutaneous electrical nerve stimulation (TENS) using an FDA-approved device via skin-surface electrodes to stimulate the S3 dermatomes by self-administration or caregiver 15 minutes daily for 4 weeks in their homes.
- Participants will receive treatment with 50 mA intensities, stimulation frequency of 25 Hz and pulse width of 400 µs in burst mode (4-second stimulation and 1-second pause) during 15 minutes, Auto-Off stimulation.
- Participants and/or caregivers will be given a video demonstration of the TENS procedure prior to commencement. Training will be provided by the investigator via a VDO conference and available on the webpage.
- Participants will be monitored weekly (for 4 weeks) via phone calls or VDO conferences to check TENS-protocol, self-report bladder diary and adverse events.
Intervention code [1] 320480 0
Treatment: Devices
Comparator / control treatment
This is a feasibility study with no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327740 0
Safety: Safety of participants using TENS will be measured by the incidence of side effects: skin irritation, pain, autonomic dysreflexia, and urinary tract infection. Side effects will be recorded daily on a self-report bladder diary. Investigator will use phone calls or VDO conferences to monitor and assess any adverse events weekly.
Timepoint [1] 327740 0
Assessed daily for the 4 week intervention
Primary outcome [2] 327741 0
Feasibility
Feasibility will use descriptive statistics to determine the dropout rate and percent of adherence to the TENS protocol.
Timepoint [2] 327741 0
4 weeks post-intervention completion
Primary outcome [3] 328049 0
Satisfaction
Satisfaction will be measured by a post-study questionnaire designed specifically for this study. It is a scale questionnaire (strongly disagree - strongly agree) to determine participants' satisfaction and experience of using TENS device.
Descriptive analysis will be conducted.
Timepoint [3] 328049 0
4 weeks post-intervention completion
Secondary outcome [1] 396394 0
Efficacy assessed using a bladder diary
This is a composite secondary outcome consisting of incontinence episodes, catheterisation frequency, and volumes voided. They will be analysed and compared to baseline measurements based on the bladder diary.
Timepoint [1] 396394 0
Assessed daily for the 4 week intervention
Secondary outcome [2] 396395 0
Efficacy assessed using the Neurogenic bladder symptom score (NBSS)
Neurogenic bladder symptom score (NBSS) will be evaluated and compared to baseline.
Timepoint [2] 396395 0
4 weeks post-interventional completion

Eligibility
Key inclusion criteria
• 18-75 years old
• Neurologically stable SCI for => 12 months
• SCI may have varying causes: traumatic and non-traumatic SCI e.g., infection, tumours, disc herniation, etc.
• Level of injury T12 or above (upper motor neuron bladder dysfunction) with no lower motor neuron lesions
• Intermittent catheterisation to empty bladder
• Stable bladder, no symptoms of urinary tract infection
• Medically stable for urination => 3 months
• Able to understand risks and benefits of participating in the study
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Normal voluntary urination control at home
• Other diagnoses to explain incontinence (urinary tract infection, bladder stones, multiple sclerosis, traumatic brain injury, stroke, etc.)
• Cutaneous pathology preventing electrode placement e.g., bedsore, pressure ulcer at the perineum
• Known lower motor neuron pathology to the sacral nerve, bladder or the lower urinary tract
• History of autonomic dysreflexia
• Inability to participate in assessments due to dementia, cognitive impairment, language difficulties
• Current pregnancy, febrile pathology, urinary tract infection, cachexia, malignant cancer, cancer at the stimulation site
• Demand-type cardiac pacemaker or implanted defibrillator

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Safety/Feasibility: We will focus on the occurrence of skin irritation or damage. For feasibility and compliance, we will calculate descriptive statistics to determine the dropout rate and percent of adherence to the prescribed regimen as well as program satisfaction. If the dropout rate is less than 25%, and if subjects complete greater than 70% of daily TENS use in the 4 weeks, we will consider the study has high feasibility/adherence. If more than 80% of subjects report that they are satisfied with the program, then we will consider the study has high satisfaction.

Efficacy: Descriptive statistics will be provided for incontinence episodes, catheterisation
frequency (count per day) and volumes voided (ml per collection). The results along the time will be compared to baseline by paired t test. Mixed-effects linear regression modelling will be used with the bladder diary variables to evaluate the changes over time adjusting for subject variability. Since this is a feasibility study, the efficacy of TENS investigated in this study will be further explored in future larger studies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2021
Actual
12/10/2021
Date of last participant enrolment
Anticipated
1/08/2022
Actual
30/05/2022
Date of last data collection
Anticipated
30/09/2022
Actual
21/08/2022
Sample size
Target
20
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 23674 0
New Zealand
State/province [1] 23674 0
Both North and South Islands

Funding & Sponsors
Funding source category [1] 308517 0
Government body
Name [1] 308517 0
NZ Lottery Health Research (R-LHR-2021-153393)
Country [1] 308517 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Centre for Brain Research
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road, Grafton
Auckland, New Zealand
1023
Country
New Zealand
Secondary sponsor category [1] 309375 0
None
Name [1] 309375 0
Address [1] 309375 0
Country [1] 309375 0
Other collaborator category [1] 281772 0
Hospital
Name [1] 281772 0
Auckland Spinal Rehabilitation Unit (ASRU)
Address [1] 281772 0
30 Bairds Road
Middlemore Hospital
Papatoetoe, Auckland
New Zealand 2025
Country [1] 281772 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308474 0
Health and Disability Ethics Committees (HDECs), Southern Health and Disability Ethics Committee
Ethics committee address [1] 308474 0
Ethics committee country [1] 308474 0
New Zealand
Date submitted for ethics approval [1] 308474 0
21/06/2021
Approval date [1] 308474 0
05/08/2021
Ethics approval number [1] 308474 0
21/STH/171

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110818 0
Dr Sam Paritt
Address 110818 0
Centre for Brain Research
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road, Grafton
Auckland, New Zealand
1023
Country 110818 0
New Zealand
Phone 110818 0
+64 0221843224
Fax 110818 0
Email 110818 0
[email protected]
Contact person for public queries
Name 110819 0
Sam Paritt
Address 110819 0
Centre for Brain Research
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road, Grafton
Auckland, New Zealand
1023
Country 110819 0
New Zealand
Phone 110819 0
+64 0221843224
Fax 110819 0
Email 110819 0
[email protected]
Contact person for scientific queries
Name 110820 0
Sam Paritt
Address 110820 0
Centre for Brain Research
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road, Grafton
Auckland, New Zealand
1023
Country 110820 0
New Zealand
Phone 110820 0
+64 0221843224
Fax 110820 0
Email 110820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.