TTNS in SCI Patients With Neurogenic Detrusor Overactivity | NCT07785258 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 25, 2026

TTNS in SCI Patients With Neurogenic Detrusor Overactivity

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.

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07785258
Lead Sponsor: National University Hospital, SingaporeOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 12Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Dec 31, 2028Estimated
Completion Date: Dec 31, 2028Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

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.
Brief 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. 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.

Conditions

The medical conditions and diseases this study investigates.

Spinal Cord Injuries
Neurogenic Detrusor Overactivity

Interventions

The treatments and procedures being evaluated in this study.

TTNS

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Gobinathan Chandran, MBBSContact

Gobinathan_CHANDRAN@nuhs.edu.sg(65) 94575924

Locations

Where the study is run and whether each site is currently recruiting.

Alexandra Hospital

Singapore, 159964, Singapore

Collaborators

The organizations and people involved in this study.

Lead Sponsor: National University Hospital, SingaporeOTHER

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Other registered studies that closely resemble this one.

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).