TTNS: Participants will undergo 28 sessions of TTNS in 4 weeks. TTNS will be administered using a neuromodulation device - Tensi+.
Study 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.
Eligibility
Sex
ALL
Min age
21 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Maximum Cystometric Capacity (MCC) — 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) — 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) — 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) — 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.
Trial sites (1)
Facility
City
Region
Status
Alexandra Hospital
Singapore
Singapore
More National University Hospital, Singapore trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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