N/A N=16 Treatment

Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation

Chronic Spinal Cord Injury · Neurogenic Bowel

Bottom Line

View on ClinicalTrials.gov: NCT03458871 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary — 0 adverse events

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 4-week TTNS home-based protocol (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	1	—
PRIMARY Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	1	—
PRIMARY Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	1	—
PRIMARY Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	1	—
PRIMARY Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	6.6	—
PRIMARY Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	6.6	—
PRIMARY Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	6.6	—
PRIMARY Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	6.6	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home	—	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home	—	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home	—	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use"	9.4	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS"	9.375	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Easy to Remember to Use TTNS"	9.875	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin"	9.375	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful"	10	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life"	5.6	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS"	8.3	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "If TTNS Works as Well as Medications, I Would Switch to TTNS"	8.4	—
PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "Overall, I Would Recommend TTNS for Those With Neurogenic Bladder"	9.7	—
SECONDARY Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey	59.1	—
SECONDARY Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey	59.1	—
SECONDARY Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey	59.1	—
SECONDARY Number of Catheterizations Per Day	5.2; 5.1; 5.4; 5.4	—
SECONDARY Volume of Catheterization	366; 332; 340.1; 342.6	—
SECONDARY Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire	0.38; 0.44; 0.38; 0.56; 0.19	—
SECONDARY Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire	0.38; 0.44; 0.38; 0.56; 0.19	—

Summary

Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in chronic SCI provided by self or caregiver for 4 weeks.

Eligibility Criteria

Inclusion Criteria

18-65 years old
Neurologically stable SCI for ≥ 6 months
Intermittent catheterization to empty bladder
Stable bladder medications for ≥ 3 months

Exclusion Criteria

Multiple medications for the bladder
Other diagnoses to explain incontinence (ex: UTI, bladder stones, multiple sclerosis, etc.)
2+ pitting edema that does not resolve
Known peripheral neuropathy or injury to the path of the tibial nerve
Demand-type cardiac pacemaker or implanted defibrillator
Cancer in the tibial nerve path and/or bladder
Inability to elicit toe/plantar flexion with electric stimulation during the clinic visit.
Inability to understand directions
Non-English speaking

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03458871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.