Spinal Cord InjuriesNCT07785258
TTNS in SCI Patients With Neurogenic Detrusor Overactivity
A study testing TTNS in people with Spinal Cord Injuries and Neurogenic Detrusor Overactivity, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This is a prospective, single-arm, pilot study to assess effectiveness and tolerability of transcutaneous tibial nerve stimulation (TTNS) in managing neurogenic detrusor overactivity in spinal cord injury patients. 12 - 16 spinal cord injury patients with neurogenic detrusor overactivity will be recruited. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Detrusor Overactivity
- What is being tested?
- TTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 21 years and 70 years old
- Clinical diagnosis of spinal cord injury
- Diagnosis of neurogenic detrusor overactivity
- Able to tolerate Urodynamic study
- Ability to provide informed consent
Who cannot join
- Patients with active implantable device or ankle orthopaedic implant, Ankle articular diseases.
- Pacemakers or implanted electrical devices, including deep brain stimulation.
- Ulceration or broken skin in area of TTNS device placement.
- Patients with BPH: predominantly voiding Lower Urinary Tract Symptoms (LUTS), Uroflow demonstrating obstructive pattern
- Active urinary tract infection
- Pregnancy
Show all 12Show fewer
- Known bladder tumour, urinary calculi
- Predominant stress urinary incontinence
- Prior treatment with transcutaneous PTNS or percutaneous PTNS (any time), sacral neuromodulation (anytime) or intradetrusor botulinum toxin injection within the past 6 months
- Past medical history of psychiatric conditions
- Patients with spinal shock
- Patients with lower motor neuron syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ning Tang, PhD contact
Singapore1 site
Alexandra Hospital
Singapore, 159964
Gobinathan Chandran, MBBS, +65 94575924, Gobinathan_CHANDRAN@nuhs.edu.sg
About this study
Official title: Pilot Study to Evaluate the Effectiveness and Tolerability of Transcutaneous Tibial Nerve Stimulation (TTNS) in Management of Neurogenic Detrusor Overactivity in Patients With Spinal Cord Injuries.
This is a prospective, single-arm, pilot study to assess effectiveness and tolerability of transcutaneous tibial nerve stimulation (TTNS) in managing neurogenic detrusor overactivity in spinal cord injury patients. 12 - 16 spinal cord injury patients with neurogenic detrusor overactivity will be recruited. The intervention includes administration of TTNS at the highest tolerated level for 20 minutes daily for 4 weeks, using a neuromodulation device -- Tensi+.
Outcome measures including Urodynamic Study (UDS) will be retrieved or collected at baseline and collected after the 4 weeks of TTNS administration. Other outcome measures include Overactive Bladder Questionnaire Short Form (OAB-Q-SF), which will be administered before and after TTNS administration, subject's level of discomfort and any adverse events experienced by the subject will be recorded after each intervention session and a bladder diary will be recorded weekly for subjects not on indwelling urinary catheters. A TTNS satisfaction survey will also be performed at the end of the study.
Read the detailed description
This study aims to evaluate the effectiveness and tolerability of TTNS in spinal cord injury patients with Neurogenic Detrusor Overactivity (NDO): a cohort of population where NDO is more prevalent but there are insufficient research and studies to look into different stimulation protocols and parameters to achieve more sustainable and longer lasting effects in patients with spinal cord injuries.
This is a prospective single-arm pilot study in spinal cord injury patients with neurogenic detrusor overactivity. Suitable subjects will be seen at the wards during their inpatient stay and will be enrolled into the study if they meet the study inclusion criteria, have no contraindication urodynamic study and are able to give informed consent.
The TTNS will be administered to subjects at the highest tolerated level for 20 minutes daily for 4 weeks. The TTNS will be administered using a neuromodulation device - Tensi+. It is a wearable device consisting of a longitudinal piece with two silicone graphite electrodes that can be strapped on the patient's ankle after application of a conductor gel. The device has a single power button to turn on/off the device and another button to adjust the level of neurostimulation, as tolerated. It has an in-built safety mechanism that will be automatically activated to limit the maximum current delivered to 50mA, at any level of intensity chosen.
Outcome measures include Urodynamic Study which will be collected at baseline (Week 0, before starting TTNS stimulations) and after the end of TTNS simulations (Week 5, after completing all TTNS stimulations). Other outcome measures include Overactive Bladder Questionnaire Short Form (OAB-Q-SF), which will be administered before (Week 0) and after TTNS administration (Week 5), subject's level of discomfort and any adverse events experienced by the subject will be recorded after each intervention session (Weeks 1-4) and a bladder diary will be recorded weekly for subjects not on indwelling urinary catheters (Weeks 1-4). A TTNS satisfaction survey will also be performed at the end of the study (Week 5).
- Being tested
- TTNS
- Keywords
- spinal cord injury, transcutaneous tibial nerve stimulation, neurogenic detrusor overactivity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTNSDevice
Participants will undergo 28 sessions of TTNS in 4 weeks. TTNS will be administered using a neuromodulation device - Tensi+.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous tibial nerve stimulation | Experimental | 28 sessions of transcutaneous tibial nerve stimulation (TTNS) in 4 weeks Receives: Device: TTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Cystometric Capacity (MCC)
Measured by Urodynamic Studies (UDS). MCC is the maximum volume of fluid the bladder can hold during filling cystometry, measured in millilitres (mL). It represents the point at which the patient feels a strong urge to void, or when the clinician decides to stop filling due to safety concerns (e.g., high pressure, leakage, or autonomic dysreflexia).
Measured: Week 0
Maximum Cystometric Capacity (MCC)
Measured by Urodynamic Studies (UDS). MCC is the maximum volume of fluid the bladder can hold during filling cystometry, measured in millilitres (mL). It represents the point at which the patient feels a strong urge to void, or when the clinician decides to stop filling due to safety concerns (e.g., high pressure, leakage, or autonomic dysreflexia).
Measured: Week 5
Detrusor Leak Point Pressure (DLPP)
Measured by Urodynamic Studies (UDS). DLPP is the detrusor pressure at which urine leaks past the outlet without any abdominal straining or detrusor contraction. It reflects the risk of upper urinary tract damage.
Measured: Week 0
Detrusor Leak Point Pressure (DLPP)
Measured by Urodynamic Studies (UDS). DLPP is the detrusor pressure at which urine leaks past the outlet without any abdominal straining or detrusor contraction. It reflects the risk of upper urinary tract damage.
Measured: Week 5
Secondary outcomes (7)
Overactive Bladder Questionnaire Short Form (OAB-Q SF)
OAB-Q SF is a patient-reported outcome measure to assess both the severity of overactive bladder symptoms and their impact on health-related quality of life. It consists of two components: a 6-item Symptom Bother scale (urgency, frequency, nocturia and urge incontinence) and a 13-item Health-Related Quality of Life scale (coping, concern, sleep and social interaction). Higher symptom scores reflect greater severity and higher Health-Related Quality of Life scores reflect better well-being.
Measured: Week 0
Overactive Bladder Questionnaire Short Form (OAB-Q SF)
OAB-Q SF is a patient-reported outcome measure to assess both the severity of overactive bladder symptoms and their impact on health-related quality of life. It consists of two components: a 6-item Symptom Bother scale (urgency, frequency, nocturia and urge incontinence) and a 13-item Health-Related Quality of Life scale (coping, concern, sleep and social interaction). Higher symptom scores reflect greater severity and higher Health-Related Quality of Life scores reflect better well-being.
Measured: Week 5
Post-TTNS survey
The Post-TTNS survey is a short questionnaire designed to gather feedback from subjects after completing the course of tibial nerve stimulaton. It assesses subject-reported outcomes such as tolerability, comfort during the stimulation, ease of use, satisfaction with the procedure, perceived changes in urinary symptoms and subject's overall experience.
Measured: Week 5
Bladder Diary
For subjects not on indwelling urinary catheters (IDC), subjects and study team will keep and record a bladder diary weekly. A bladder diary is used to record daily urinary habits, providing an objective record of the subject's bladder function to assess urinary symptoms.
Measured: Week 1
Bladder Diary
For subjects not on indwelling urinary catheters (IDC), subjects and study team will keep and record a bladder diary weekly. A bladder diary is used to record daily urinary habits, providing an objective record of the subject's bladder function to assess urinary symptoms.
Measured: Week 2
Bladder Diary
For subjects not on indwelling urinary catheters (IDC), subjects and study team will keep and record a bladder diary weekly. A bladder diary is used to record daily urinary habits, providing an objective record of the subject's bladder function to assess urinary symptoms.
Measured: Week 3
Bladder Diary
For subjects not on indwelling urinary catheters (IDC), subjects and study team will keep and record a bladder diary weekly. A bladder diary is used to record daily urinary habits, providing an objective record of the subject's bladder function to assess urinary symptoms.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, pilot study to assess effectiveness and tolerability of TTNS in managing neurogenic detrusor overactivity in spinal cord injury patients.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gobinathan Chandran, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785258
- Sponsor's protocol ID
- 2025/0862
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effectiveness and Tolerability of Transcutaneous Tibial Nerve Stimulation (TTNS) in Management of Neurogenic Detrusor Overactivity in Patients With Spinal Cord Injuries.
- ClinicalTrials.gov ID
- NCT07785258
- Acronym / sponsor ID
- 2025/0862
- Keywords
- spinal cord injury, transcutaneous tibial nerve stimulation, neurogenic detrusor overactivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, pilot study to assess effectiveness and tolerability of transcutaneous tibial nerve stimulation (TTNS) in managing neurogenic detrusor overactivity in spinal cord injury patients. 12 - 16 spinal cord injury patients with neurogenic detrusor overactivity will be recruited. The intervention includes administration of TTNS at the highest tolerated level for 20 minutes daily for 4 weeks, using a neuromodulation device -- Tensi+.
Outcome measures including Urodynamic Study (UDS) will be retrieved or collected at baseline and collected after the 4 weeks of TTNS administration. Other outcome measures include Overactive Bladder Questionnaire Short Form (OAB-Q-SF), which will be administered before and after TTNS administration, subject's level of discomfort and any adverse events experienced by the subject will be recorded after each intervention session and a bladder diary will be recorded weekly for subjects not on indwelling urinary catheters. A TTNS satisfaction survey will also be performed at the end of the study.
Detailed description
This study aims to evaluate the effectiveness and tolerability of TTNS in spinal cord injury patients with Neurogenic Detrusor Overactivity (NDO): a cohort of population where NDO is more prevalent but there are insufficient research and studies to look into different stimulation protocols and parameters to achieve more sustainable and longer lasting effects in patients with spinal cord injuries.
This is a prospective single-arm pilot study in spinal cord injury patients with neurogenic detrusor overactivity. Suitable subjects will be seen at the wards during their inpatient stay and will be enrolled into the study if they meet the study inclusion criteria, have no contraindication urodynamic study and are able to give informed consent.
The TTNS will be administered to subjects at the highest tolerated level for 20 minutes daily for 4 weeks. The TTNS will be administered using a neuromodulation device - Tensi+. It is a wearable device consisting of a longitudinal piece with two silicone graphite electrodes that can be strapped on the patient's ankle after application of a conductor gel. The device has a single power button to turn on/off the device and another button to adjust the level of neurostimulation, as tolerated. It has an in-built safety mechanism that will be automatically activated to limit the maximum current delivered to 50mA, at any level of intensity chosen.
Outcome measures include Urodynamic Study which will be collected at baseline (Week 0, before starting TTNS stimulations) and after the end of TTNS simulations (Week 5, after completing all TTNS stimulations). Other outcome measures include Overactive Bladder Questionnaire Short Form (OAB-Q-SF), which will be administered before (Week 0) and after TTNS administration (Week 5), subject's level of discomfort and any adverse events experienced by the subject will be recorded after each intervention session (Weeks 1-4) and a bladder diary will be recorded weekly for subjects not on indwelling urinary catheters (Weeks 1-4). A TTNS satisfaction survey will also be performed at the end of the study (Week 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, pilot study to assess effectiveness and tolerability of TTNS in managing neurogenic detrusor overactivity in spinal cord injury patients.
| Arm | Type | Receives |
|---|---|---|
| transcutaneous tibial nerve stimulation | Experimental | Device: TTNS28 sessions of transcutaneous tibial nerve stimulation (TTNS) in 4 weeks |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 21 years and 70 years old
- Clinical diagnosis of spinal cord injury
- Diagnosis of neurogenic detrusor overactivity
- Able to tolerate Urodynamic study
- Ability to provide informed consent
Key exclusion criteria (12 listed)
- Patients with active implantable device or ankle orthopaedic implant, Ankle articular diseases.
- Pacemakers or implanted electrical devices, including deep brain stimulation.
- Ulceration or broken skin in area of TTNS device placement.
- Patients with BPH: predominantly voiding Lower Urinary Tract Symptoms (LUTS), Uroflow demonstrating obstructive pattern
- Active urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTNSParticipants will undergo 28 sessions of TTNS in 4 weeks. TTNS will be administered using a neuromodulation device - Tensi+. | Device | transcutaneous tibial nerve stimulation |
Primary outcome
Maximum Cystometric Capacity (MCC)
Time frame: Week 0
Measured by Urodynamic Studies (UDS). MCC is the maximum volume of fluid the bladder can hold during filling cystometry, measured in millilitres (mL). It represents the point at which the patient feels a strong urge to void, or when the clinician decides to stop filling due to safety concerns (e.g., high pressure, leakage, or autonomic dysreflexia).
Maximum Cystometric Capacity (MCC)
Time frame: Week 5
Measured by Urodynamic Studies (UDS). MCC is the maximum volume of fluid the bladder can hold during filling cystometry, measured in millilitres (mL). It represents the point at which the patient feels a strong urge to void, or when the clinician decides to stop filling due to safety concerns (e.g., high pressure, leakage, or autonomic dysreflexia).
Detrusor Leak Point Pressure (DLPP)
Time frame: Week 0
Measured by Urodynamic Studies (UDS). DLPP is the detrusor pressure at which urine leaks past the outlet without any abdominal straining or detrusor contraction. It reflects the risk of upper urinary tract damage.
Detrusor Leak Point Pressure (DLPP)
Time frame: Week 5
Measured by Urodynamic Studies (UDS). DLPP is the detrusor pressure at which urine leaks past the outlet without any abdominal straining or detrusor contraction. It reflects the risk of upper urinary tract damage.
7 secondary outcomes
Overactive Bladder Questionnaire Short Form (OAB-Q SF)
Time frame: Week 0
Overactive Bladder Questionnaire Short Form (OAB-Q SF)
Time frame: Week 5
Post-TTNS survey
Time frame: Week 5
Bladder Diary
Time frame: Week 1
Bladder Diary
Time frame: Week 2
Bladder Diary
Time frame: Week 3
Bladder Diary
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Tang, PhD contact
Gobinathan Chandran, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTNS in people with Spinal Cord Injuries and Neurogenic Detrusor Overactivity, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gobinathan Chandran, MBBS ((65) 94575924, Gobinathan_CHANDRAN@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Cystometric Capacity (MCC) (time frame: Week 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.