Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

Browse trials for

• Spinal Cord Injuries 1,948
• Urinary Bladder, Neurogenic 185

Keywords

• spinal cord injury
• tibial nerve stimulation

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Study arms

• Experimental
  Vivally system

  Device: Vivally system stimulation

Interventions

• DeviceVivally system stimulation

  During the first month, participants will do the stimulation at different time points: 1) supine while in bed, 2) seated in the morning, 3) sitting in the afternoon, and 4) sitting in the evening. Participants will measure the circumference of their ankle prior to each use. Participants will use the System for an additional 2 months with the preferred stimulation parameters based on the study team's recommendations from the first month of use.

Primary outcomes

1. Consistency and Reliability of Stimulation Output as assessed by the percentage of sessions where the desired stimulation intensity is achieved (based on EMG waveform consistency) and time of day (morning, afternoon, evening)

   Time frame: Daily during the 4-week optimization period

2. EMG Waveform Quality as assessed by the number of successful EMG detections per session versus unsuccessful ones

   Time frame: Daily during the 4-week optimization period

3. Safety as assessed by the Pain score reported on the participant diary

   Pain is scored on linear scale from 0(no pain)-10(worst pain), higher score indicating worse outcome

   Time frame: Continuous, daily monitoring throughout the 12-week study

4. Safety as assessed by the adverse events self reported by participant

   patient-reported adverse events, including changes in spasticity, their bowel programs, urinary tract infections, autonomic dysreflexia, and all other concerning changes

   Time frame: Continuous, daily monitoring throughout the 12-week study

5. Feasibility as assessed by the number of participants who adhere to the protocol as reported on the patient dairy

   Time frame: Weekly during the 12-week study

6. Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data

   Time frame: 2 days per month for all three months

7. Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data

   Time frame: 2 days per month for all three months

8. Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data

   Time frame: 2 days per month for all three months

9. Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data

   Time frame: Once a month for all 3 months

10. Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data

    Time frame: Once a month for all 3 months

11. Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data

    Time frame: Once a month for all 3 months

12. Implementation Barriers as assessed by a survey

    Time frame: end of study (12 weeks from baseline)

13. Patient-Reported Implementation Feedback as assessed by a survey

    Time frame: end of study (12 weeks from baseline)

Secondary outcomes

1. Patient-Reported Comfort as assessed by the participant survey

   Time frame: Daily during the 4-week optimization period

2. Patient-Reported Usability as assessed by the participant survey

   Time frame: Daily during the 4-week optimization period

3. Type and extent of adjustments (none, minor, major) required for System Operation needed for effective stimulation

   Time frame: End of the 4-week optimization period

4. Frequency of adaptations made to the device

   Time frame: End of the 4-week optimization period

5. Number of participants that had adaptations made to the device as assessed by a yes or no questionnaire

   Time frame: End of the 4-week optimization period

6. Change in Quality of Life as assessed by the The Neurogenic Bladder Symptom Score (NBSS)

   This is a 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23) for a maximum score of 74, higher scores indicating worse outcome

   Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks

7. Change in Quality of Life as assessed by the Incontinence Quality of Life Questionnaire(I-QOL)

   The I-QOL is a 22-item self-reported questionnaire scored on a scale from 0 to 100, with higher scores indicating better quality of life.

   Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks

8. Change in Quality of Life as assessed by the Neurogenic Bowel Dysfunction (NBD) score

   The NBD score evaluates symptoms such as incontinence, constipation, and frequency of bowel management interventions. It is scored on a scale from 0 to 47, with higher scores indicating more severe dysfunction.

   Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks

9. Patient satisfaction as assessed by a survey

   This is an 8 item questionnaire and each is scored between 1(strongly disagree)-5( strongly agree),maximum score of 40, higher score indicates better satisfaction with the device

   Time frame: End of study (12 weeks form baseline)

10. Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot

    Time frame: Weekly during the 12-week study

11. Patient-Reported Changes in Bladder Program

    Documentation of any changes made to the bladder management program

    Time frame: Weekly during the 12-week study

12. Number of caregivers who were satisfied as assessed by the interview

    Time frame: end of study (12 weeks from baseline)

13. Number of clinicians who were satisfied as assessed by the interview

    Time frame: end of study (12 weeks from baseline)

14. System Fidelity as assessed by the degree to which the the Avation electric stimulation system was used as intended by patients

    This is assessed by the the number of times participant used the device per month

    Time frame: end of study (12 weeks from baseline)

15. Relative Advantage and Adaptability of the Innovation as assessed by the ratings on the perceived benefits and adaptability of the the Avation electric stimulation system compared to existing treatments

    Time frame: end of study (12 weeks from baseline)

Individual participant data

Plan to share: No