Clinical trial NCT03458871: Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Official title: Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Spinal Cord Injury
Neurogenic Bowel
Keywords: electric stimulation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: In Specific Aim 1, we will monitor for safety, feasibility, and compliance of a home TTNS program for bladder management. In Specific Aim 2, the efficacy of home TTNS will be compared to baseline Incontinence- Quality of Life questionnaire. A bladder diary will also capture important information such as frequency and volume of catheterization, incontinence episodes, and other related observations.

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

Primary outcomes:
measure: Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
timeFrame: week 1
measure: Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
timeFrame: week 2
measure: Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
timeFrame: week 3
measure: Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
timeFrame: week 4
measure: Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
timeFrame: week 1
measure: Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
timeFrame: week 2
measure: Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
timeFrame: week 3
measure: Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
timeFrame: week 4
measure: Overall Satisfaction of Daily Use of TTNS at Home
timeFrame: week 1
measure: Overall Satisfaction of Daily Use of TTNS at Home
timeFrame: week 2
measure: Overall Satisfaction of Daily Use of TTNS at Home
timeFrame: week 3
measure: Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use"
timeFrame: week 4
measure: Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS"
timeFrame: week 4
measure: 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"
timeFrame: week 4
measure: Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin"
timeFrame: week 4
measure: Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful"
timeFrame: week 4
measure: Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life"
timeFrame: week 4
measure: Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS"
timeFrame: week 4
measure: 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"
timeFrame: week 4
measure: 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"
timeFrame: week 4
Secondary outcomes:
measure: Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
timeFrame: week 0
measure: Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
timeFrame: Week 2
measure: Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
timeFrame: week 4
measure: Number of Catheterizations Per Day
timeFrame: week 1, week 2, week 3, week 4
measure: Volume of Catheterization
timeFrame: week 1, week 2, week 3, week 4
measure: Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
timeFrame: week 0
measure: Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
timeFrame: week 4
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Argyrios Stampas, MD
role: PRINCIPAL_INVESTIGATOR
References: