TTNS in SCI Patients With Neurogenic Detrusor Overactivity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorNational University Hospital, Singapore
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged between 21 years and 70 years old
Clinical diagnosis of spinal cord injury
Diagnosis of neurogenic detrusor overactivity
Able to tolerate Urodynamic study
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
TTNS
DeviceParticipants will undergo 28 sessions of TTNS in 4 weeks. TTNS will be administered using a neuromodulation device - Tensi+.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: transcutaneous tibial nerve stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Week 02
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).
Time frame
Week 53
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.
Time frame
Week 04
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.
Time frame
Week 5Secondary outcomes
1
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.
Time frame
Week 02
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.
Time frame
Week 53
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.
Time frame
Week 54
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.
Time frame
Week 1Sponsors and contacts
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Source ClinicalTrials.gov
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