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.
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ning Tang, PhD
- E-mail: ning_tang@nuhs.edu.sg
Sauvegarde des contacts de l'étude
- Nom: Gobinathan Chandran, MBBS
- Numéro de téléphone: (65) 94575924
- E-mail: Gobinathan_CHANDRAN@nuhs.edu.sg
Lieux d'étude
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Singapore, Singapour, 159964
- Alexandra Hospital
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Contact:
- Gobinathan Chandran, MBBS
- Numéro de téléphone: +65 94575924
- E-mail: Gobinathan_CHANDRAN@nuhs.edu.sg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: transcutaneous tibial nerve stimulation
28 sessions of transcutaneous tibial nerve stimulation (TTNS) in 4 weeks
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Participants will undergo 28 sessions of TTNS in 4 weeks.
TTNS will be administered using a neuromodulation device - Tensi+.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Maximum Cystometric Capacity (MCC)
Délai: Week 0
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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).
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Week 0
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Maximum Cystometric Capacity (MCC)
Délai: Week 5
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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).
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Week 5
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Detrusor Leak Point Pressure (DLPP)
Délai: Week 0
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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.
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Week 0
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Detrusor Leak Point Pressure (DLPP)
Délai: Week 5
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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.
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Week 5
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overactive Bladder Questionnaire Short Form (OAB-Q SF)
Délai: Week 0
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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.
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Week 0
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Overactive Bladder Questionnaire Short Form (OAB-Q SF)
Délai: Week 5
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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.
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Week 5
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Post-TTNS survey
Délai: Week 5
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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.
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Week 5
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Bladder Diary
Délai: Week 1
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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.
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Week 1
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Bladder Diary
Délai: Week 2
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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.
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Week 2
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Bladder Diary
Délai: Week 3
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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.
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Week 3
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Bladder Diary
Délai: Week 4
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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.
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Week 4
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gobinathan Chandran, MBBS, National University Hospital, Singapore
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025/0862
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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