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Behavioural Intervention

TTNS for Neurogenic Bladder (TTNS1yr Trial)

N/A

Recruiting

Led By Suzanne Groah, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

T9 level of injury and above who are at greatest risk of morbid NGB

Diagnosed with traumatic or non-traumatic SCI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post sci

Awards & highlights

TTNS1yr Trial Summary

This trial will test if TTNS can help improve bladder function in people with acute spinal cord injury.

Who is the study for?

This trial is for adults aged 18-75 with a spinal cord injury at T9 level or above, who are within 6 weeks of inpatient rehabilitation and can follow up regionally. Participants must speak English or Spanish. Excluded are those with tibial nerve damage, toe flexion issues during tests, pregnancy, pre-injury neuropathy symptoms, progressive SCI conditions like ALS or MS, genitourinary disorders history, CNS disorders history.Check my eligibility

What is being tested?

The study examines if transcutaneous tibial nerve stimulation (TTNS), an electric leg stimulation therapy given either five times a week or twice a week at variable doses or as a fixed dose protocol can improve bladder control in patients with recent acute spinal cord injuries.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the leg and possible skin irritation due to repeated use of the TTNS device. There might also be unintended muscle twitches during stimulation.

TTNS1yr Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal injury is above the T9 level and I'm at high risk of severe bladder problems.

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I have a spinal cord injury.

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I am between 18 and 75 years old.

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I have a spinal cord injury.

TTNS1yr Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post sci

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post sci

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post sci for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in bladder pathology from 4 month presence of detrusor overactivity and DSD as assessed by the urodynamics study at 1 year post SCI.

Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.

Maintained bladder capacity as assessed by the Urodynamics study measured in ml

+1 more

Secondary outcome measures

Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey

Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)

Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes

TTNS1yr Trial Design

3Treatment groups

Active Control

Group I: Variable-dose TTNS Protocol 5 x weekActive Control1 Intervention

TTNS protocol: Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. All participants will be instructed to use the device for 30 minutes, 5 days per week for the first 4 months post-sci.

Group II: Fixed-dose TTNS protocolActive Control1 Intervention

Fixed-dose protocol: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. Both variable-dose TTNS and fixed-dose TTNS protocol participants will be instructed to use the device for 30 minutes, 5 days per week.

Group III: Variable-dose TTNS Protocol 2 x weekActive Control1 Intervention

At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedStar National Rehabilitation NetworkOTHER

13 Previous Clinical Trials

4,460 Total Patients Enrolled

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,877 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,255 Total Patients Enrolled

Media Library

Spinal Cord Injury Research Study Groups: Variable-dose TTNS Protocol 5 x week, Fixed-dose TTNS protocol, Variable-dose TTNS Protocol 2 x week

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to be involved in this investigation?

"Affirmative. The clinicaltrials.gov database reveals that this research study, established on June 8th 2020, is currently enrolling participants. A total of 120 volunteers are sought from two separate locations."

Answered by AI

Is there an age limit to participation in this research endeavor?

"This trial is open to individuals between 18 and 75 years old. There are 151 trials available for minors, while those over 65 can join 746 different clinical studies."

Answered by AI

How many individuals are being included in the experiment?

"Affirmative. Clinical trials data on clinicaltrials.gov reveals that this scientific investigation, which was initially posted on 8th June 2020, is currently enrolling patients. Approximately 120 individuals must be acquired from 2 various medical locations."

Answered by AI

To whom does this research study extend its invitation?

"This trial seeks 120 patients who have sustained a spinal cord injury between the ages of 18 and 75. To be considered, individuals must meet certain conditions; they must fall within this age bracket, their SCI can either be traumatic or non-traumatic in nature, they should have been admitted to an inpatient rehabilitation facility within 6 weeks of incurring the injury, live close enough for regular follow-up visits to take place, and it is preferable that those with T9 level injuries or higher join as these are at greatest risk of morbid neurogenic bladder problems."

Answered by AI