Neurogenic Bladder (NB), Spinal Cord Injury (SCI)
Conditions
Brief summary
The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.
Interventions
DEVICEiTNS
The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.
DEVICESham iTNS
The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.
Sponsors
The University of Texas Health Science Center, Houston
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Non-progressive chronic (\>1 year) SCI * Neurologic level of injury T9 and above * Stable over active bladder (OAB) medications (≥3 months) * No contraindication to MRI (per MRI Safety Questionnaire) * English or Spanish speaking * Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted) * Pass the tTNS competency checklist to perform or direct performance of tTNS.
Exclusion criteria
* Ongoing/active genitourinary oncologic diagnoses * History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy * Pregnancy or planning to become pregnant. * Lower Motor Neuron bladder * Restorative bladder surgery such as augmentation cystoplasty * Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed) * Anticoagulation treatment or prophylaxis * Advanced peripheral vascular disease (gangrene, amputation, etc.) * History of intolerance to electrical stimulation, particularly of the leg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by the number of device-related adverse events | From baseline to 8 weeks | Adverse events include lead migration and fracture, hematoma, wound infection, delayed healing, nerve injury, and autonomic dysreflexia occurrence during the procedure. |
| Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs. | From baseline to week 8 | — |
| Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy | From baseline to week 8 | — |
| Feasibility of Injectrode procedure as assessed by surveys | Week 8 | Feasibility to check if reproducible training pathway can enable non-interventional physicians to competently perform Injectrode implantation and removal |
| Physician acceptability of Injectrode device as assessed by a survey | Week 8 | The acceptability survey ranges from 0 - 32, with a higher score indicating greater acceptability of the Injectrode device. |
| Participant acceptability of Injectrode device as assessed by a survey | Week 8 | The acceptability survey ranges from 0 - 25, with a higher score indicating greater acceptability of the Injectrode device. |
| Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview | Week 8 | A semi-structured interview will be conducted with participants and providers to explore their perceptions of the Injectrode treatment. Responses will be summarized using qualitative coding and descriptive statistics of themes. |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants for whom bladder medication dosage reduced | from baseline to 8 weeks |
| Change in magnitude of dosage of medication | from baseline to 8 weeks |
| Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20. | Baseline, Week 4, and Week 8 |
| Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics. | baseline, Week 4, and Week 8 |
| Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort. | baseline, Week 4, and Week 8 |
| Change in the presence or absence of leaks during urodynamics. | baseline, Week 4, and Week 8 |
| Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling. | baseline, Week 4, and Week 8 |
| Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency/ desire to void. | Baseline, Week 4, and Week 8 |
| Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort. | Baseline, Week 4, and Week 8 |
| Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure. | baseline, Week 4, and Week 8 |
| Change in the number of incontinence episodes as self-reported in the bladder diary. | Baseline, Week 4, and Week 8 |
| Change in the frequency of catheterization as self-reported in the bladder diary. | Baseline, Week 4, and Week 8 |
| Change in the volume of catheterization as self-reported in the bladder diary. | Baseline, Week 4, and Week 8 |
Countries
United States
Contacts
CONTACTArgyrios Stampas, MD
CONTACTDanira Garcia Gutierrez
PRINCIPAL_INVESTIGATORArgyrios Stampas, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed