A gentle zap to the ankle might restore bladder control after spinal injury

NCT ID NCT07785258

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This pilot trial tests whether a non-invasive nerve stimulation technique, called transcutaneous tibial nerve stimulation (TTNS), can help people with spinal cord injuries who have overactive bladder muscles. Participants will use a small device to deliver mild electrical pulses to the ankle for 20 minutes daily over four weeks. Researchers will measure bladder capacity and pressure before and after treatment, along with symptom questionnaires and satisfaction surveys, to see if the approach is both effective and comfortable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous tibial nerve stimulation (TTNS) using a neuromodulation device (Tensi+)
What this could lead to
If effective, TTNS could offer a non-invasive, drug-free way to improve bladder control and protect the kidneys in people with spinal cord injuries.
What could go wrong
This is a small pilot study with only 12 participants, so results may not apply broadly. The treatment may not improve bladder function, and some people may find the stimulation uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged between 21 years and 70 years old 2. Clinical diagnosis of spinal cord injury 3. Diagnosis of neurogenic detrusor overactivity 4. Able to tolerate Urodynamic study 5. Ability to provide informed consent Exclusion Criteria: 1. Patients with active implantable device or ankle orthopaedic implant, Ankle articular diseases. 2. Pacemakers or implanted electrical devices, including deep brain stimulation. 3. Ulceration or broken skin in area of TTNS device placement. 4. Patients with BPH: predominantly voiding Lower Urinary Tract Symptoms (LUTS), Uroflow demonstrating obstructive pattern 5. Active urinary tract infection 6. Pregnancy 7. Known bladder tumour, urinary calculi 8. Predominant stress urinary incontinence 9. Prior treatment with transcutaneous PTNS or percutaneous PTNS (any time), sacral neuromodulation (anytime) or intradetrusor botulinum toxin injection within the past 6 months 10. Past medical history of psychiatric conditions 11. Patients with spinal shock 12. Patients with lower motor neuron syndrome

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Alexandra Hospital

    Singapore, 159964, Singapore

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