TTNS for Neurogenic Bladder (TTNS1yr Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByArgyrios Stampas, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.
How does the treatment TTNS for neurogenic bladder differ from other treatments?
TTNS (Transcutaneous Tibial Nerve Stimulation) is unique because it uses electrical stimulation applied through the skin to target the tibial nerve, offering a non-invasive alternative to other methods like PTNS (Percutaneous Tibial Nerve Stimulation), which requires needle insertion. This makes TTNS a more comfortable and accessible option for patients.
23467Is transcutaneous tibial nerve stimulation (TTNS) safe for humans?
Transcutaneous tibial nerve stimulation (TTNS) is considered a safe treatment for conditions like overactive bladder in adults, as indicated by studies comparing it to other therapies.
14568What data supports the effectiveness of the treatment Transcutaneous Tibial Nerve Stimulation (TTNS) for neurogenic bladder?
Research shows that Transcutaneous Tibial Nerve Stimulation (TTNS) is effective for various bladder issues, like overactive bladder and bladder pain syndrome, suggesting it could help with neurogenic bladder too.
34678Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
Eligibility Criteria
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.Inclusion Criteria
My spinal injury is above the T9 level and I'm at high risk of severe bladder problems.
I have a spinal cord injury.
I am between 18 and 75 years old.
I have a spinal cord injury.
Exclusion Criteria
I have had nerve damage in my hands or feet.
I had symptoms like numbness or pain in my feet before my spinal cord injury.
I have nerve damage due to an injury in my lower back or pelvis.
I have a history of a central nervous system disorder.
My condition may worsen and includes ALS, MS, or spinal cancer.
Participant Groups
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.
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.
Transcutaneous Tibial Nerve Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as TTNS for:
- Overactive bladder
- Urinary frequency
- Urinary urgency
- Urge incontinence
🇪🇺 Approved in European Union as TTNS for:
- Overactive bladder
- Urinary frequency
- Urinary urgency
- Urge incontinence
🇨🇦 Approved in Canada as TTNS for:
- Overactive bladder
- Urinary frequency
- Urinary urgency
- Urge incontinence
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
MedStar National Rehabilitation HospitalWashington, United States
TIRR Memorial Hermann Research CenterHouston, TX
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
MedStar National Rehabilitation NetworkCollaborator
The Methodist Hospital Research InstituteCollaborator
References
Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. [2022]Objectives. To investigate feasibility and safety of implant-driven tibial nerve stimulation. Materials and Methods. Eight patients with refractory overactive bladder were successfully treated with implanted percutaneous tibial nerve stimulation (PTNS). Patients were evaluated with bladder diaries, quality of life questionnaires, and physical examination before implantation, and at 3, 6, and 12 months of follow-up. The primary objective was ≥ 50% reduction of the number of incontinence episodes and/or voids on bladder diary. The Wilcoxon signed ranks test was used. Results. At 3, 6 and 12 months, respectively five, six, and four patients met the primary objective. At 3- and 6-month follow-up, voiding and quality of life parameters had significantly (p
The efficacy of posterior tibial nerve stimulation for the treatment of overactive bladder in women: a systematic review. [2021]Posterior tibial nerve stimulation (PTNS) is a percutaneous method of peripheral, sacral neuromodulation. Its current use is limited; however, published data suggest PTNS may be an effective treatment for overactive bladder (OAB).
Frequency-dependent inhibition of bladder function by saphenous nerve stimulation in anesthetized rats. [2019]Percutaneous tibial nerve stimulation (PTNS) is an effective neuromodulation therapy for treating overactive bladder (OAB). The therapeutic effects are achieved by repeatedly applying electrical stimulation through a percutaneous needle electrode that is used to target the tibial nerve (TN). Anatomical studies indicate there can be multiple saphenous nerve (SAFN) branches located near the site of electrical stimulation, and therefore we investigated the possibility of evoking a bladder-inhibitory reflex by electrically activating the SAFN.
Randomized Crossover-Controlled Evaluation of Simultaneous Bilateral Transcutaneous Electrostimulation of the Posterior Tibial Nerve During Urodynamic Studies in Patients With Lower Urinary Tract Symptoms. [2022]Transcutaneous tibial nerve stimulation (TTNS) has proven to be a valuable treatment option for various lower urinary tract conditions, such as overactive bladder syndrome and neurogenic detrusor overactivity. The aim of this study was to investigate acute changes in urodynamic parameters due to bilateral TTNS.
Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofold double-blinded randomized controlled TaPaS trial. [2021]Transcutaneous tibial nerve stimulation (TTNS) and percutaneous tibial nerve stimulation (PTNS) are effective and safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham-controlled trials have been conducted in a pediatric population. To our knowledge, both therapies never have been compared in children.
Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. [2023]We aim to compare the safety and effectiveness of transcutaneous tibial nerve stimulation (TTNS) versus percutaneous tibial nerve stimulation (PTNS) in treating overactive bladder.
Percutaneous versus Transcutaneous Electrical Stimulation of the Posterior Tibial Nerve in Idiopathic Overactive Bladder Syndrome with Urinary Incontinence in Adults: A Systematic Review. [2021]Percutaneous electrical stimulation and transcutaneous electrical stimulation (PTNS and TTNS) of the posterior tibial nerve are internationally recognized treatment methods that offer advantages in terms of treating patients with overactive bladder (OAB) who present with urinary incontinence (UI). This article aims to analyze the scientific evidence for the treatment of OAB with UI in adults using PTNS versus TTNS procedures in the posterior tibial nerve.
Efficacy of transcutaneous tibial nerve stimulation in the treatment of bladder pain syndrome. [2023]This study aimed to demonstrate the effectiveness of transcutaneos tibial nerve stimulation (TTNS) in the treatment of bladder pain syndrome (BPS).