TTNS in SCI Patients With Neurogenic Detrusor Overactivity

NCT07785258 | Not Yet Recruiting

• 1 other identifier: 2025/0862
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Spinal Cord Injuries; Neurogenic Detrusor Overactivity

Keywords

spinal cord injury; transcutaneous tibial nerve stimulation; neurogenic detrusor overactivity

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  Week 5

Secondary Outcomes (7)

• Overactive Bladder Questionnaire Short Form (OAB-Q SF)

  Week 0

• Overactive Bladder Questionnaire Short Form (OAB-Q SF)

  Week 5

• Post-TTNS survey

  Week 5

• Bladder Diary

  Week 1

• Bladder Diary

  Week 2

Study Arms (1)

transcutaneous tibial nerve stimulation

EXPERIMENTAL

28 sessions of transcutaneous tibial nerve stimulation (TTNS) in 4 weeks

Device: TTNS

Interventions

TTNS DEVICE

Participants will undergo 28 sessions of TTNS in 4 weeks. TTNS will be administered using a neuromodulation device - Tensi+.

transcutaneous tibial nerve stimulation

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Alexandra Hospital

Singapore, 159964, Singapore

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Gobinathan Chandran, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gobinathan Chandran, MBBS

CONTACT

(65) 94575924; Gobinathan_CHANDRAN@nuhs.edu.sg

Ning Tang, PhD

CONTACT

ning_tang@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 25, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)