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Clinical Trial NCT07343583 for Spinal Cord Injury, Detrusor Overacitivity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of Sacral and Tibial Stimulation on Bladder Function in Subacute Suprasacral Spinal Cord Injury 45 Non-Invasive Randomized Prevention
Clinical Trial NCT07343583 is an interventional study for Spinal Cord Injury, Detrusor Overacitivity that is recruiting. It started on August 5, 2025 with plans to enroll 45 participants. Led by Ankara City Hospital Bilkent, it is expected to complete by April 1, 2026. The latest data from ClinicalTrials.gov was last updated on January 15, 2026.
Brief Summary
Suprasacral spinal cord injury (SCI) frequently leads to neurogenic detrusor overactivity (NDO), resulting in elevated bladder storage pressures, urinary incontinence, and an increased risk of upper urinary tract damage. Early regulation of bladder function is a key objective of SCI rehabilitation, particularly during the subacute phase when pathological spinal reflex pathways are still developing.
Pharmacological t...
Show MoreDetailed Description
Neurogenic detrusor overactivity (NDO) is a common consequence of suprasacral spinal cord injury (SCI) and represents a major risk factor for urinary incontinence and upper urinary tract deterioration. During the subacute phase following SCI, maladaptive spinal reflex pathways associated with detrusor overactivity are still evolving. Interventions applied during this period may influence the development and severity ...Show More
Official Title
Effectiveness of Transcutaneous Tibial and Sacral Nerve Stimulation in Preventing the Development of Detrusor Overactivity in Patients With Subacute Suprasacral Spinal Cord Injury
Conditions
Spinal Cord InjuryDetrusor OveracitivityPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2-25-900
NCT ID Number
Start Date (Actual)
2025-08-05
Last Update Posted
2026-01-15
Completion Date (Estimated)
2026-04-01
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
transcutaneous sacral stimulation
transcutaneous tibial stimulation
detrusor overactivity
neurogenic bowel dysfunction
subacute spinal cord injury
transcutaneous tibial stimulation
detrusor overactivity
neurogenic bowel dysfunction
subacute spinal cord injury
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active Comparatortranscutaneous tibial nerve stimulation Subacute suprasacral spinal cord injury patients receiving transcutaneous tibial nerve stimulation. | Transcutaneous Tibial Nerve Stimulation For patients in the TTNS group, two adhesive surface electrodes will be placed: the negative electrode immediately behind the right medial malleolus, and the positive electrode 10 cm above the negative electrode along the tibial nerve. The correct position of the negative electrode will be confirmed by the visualization of the flexion of the big toe or toes, which spreads with increasing current intensity. Stimulatio...Show More |
Active Comparatortranscutaneous sacral nerve stimulation Subacute suprasacral spinal cord injury patients receiving transcutaneous sacral nerve stimulation. | Transcutaneous Sacral Nerve Stimulation For the TSNS group, electrodes will be placed symmetrically 5 cm lateral to both sides at the level determined by manual palpation of the sacrum over the S3 foramen, and the current intensity will be increased until contraction is observed in the patient's external anal sphincter. The current frequency will be 20 Hz, the impulse duration will be 200 microseconds, and the treatment will be administered 15 times at 30-...Show More |
No InterventionControl group Data from patients who have not undergone any stimulation prior to urodynamics in the standard protocol will be used. Urodynamic results will be evaluated by comparing them between groups. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Comparison of urodynamic data in patients with subacute suprasacral spinal cord injury | The primary outcome is the comparison of urodynamic parameters among three groups: tibial nerve stimulation, sacral stimulation, and control group without stimulation in patients with subacute suprasacral spinal cord injury | A single urodynamic assessment is performed immediately after completion of the 3-week stimulation protocol (no later than 24 hours after the final session) and once for each patient. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Neurogenic Bladder Dysfunction Score | It is a score specifically developed to assess symptoms and outcomes associated with neurogenic bladder dysfunction. It is a 24-item questionnaire (0-74 points). The higher the score, the greater the severity of symptoms. Its validity and reliability in Turkish have been demonstrated. | This measurement will be performed twice. 1. During the initial evaluation of the patient (before stimulation has begun) 2. One month after the completion of urodynamic testing in patients who have completed stimulation |
Neurogenic Bowel Dysfunction Score | It was developed to assess neurogenic bowel dysfunction in patients with spinal cord injury. It consists of 10 items related to the impaired quality of life caused by bowel symptoms. Its validity and reliability in Turkish have been demonstrated. | This measurement will be performed twice. 1. During the initial evaluation of the patient (before stimulation has begun) 2. One month after the completion of urodynamic testing in patients who have completed stimulation |
Spinal Cord Independence Measure III (SCIM III) | It is specifically designed to cover all aspects related to individuals with SCI, including self-care ability, respiratory and sphincter management, and daily mobility. SCIM results reflect the independence of individuals with SCI; a higher score indicates that very little assistance or fewer helpers are needed to complete basic daily living and life support activities. | This measurement will be performed twice. 1. During the initial evaluation of the patient (before stimulation has begun) 2. One month after the completion of urodynamic testing in patients who have completed stimulation |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- ≥18-65 years of age
- Injury duration <6 months
- Traumatic and non-traumatic SCI;
- Patients with spinal cord injury above T11
- Patients with a cardiac pacemaker
- Patients with other neurological diseases that may affect neurogenic bladder (Parkinson's disease, polyneuropathy, neurodegenerative disease, cerebrovascular disease, etc.)
- Patients with structural abnormalities in the genitourinary system (pelvic floor dysfunction, BPH, etc.)
- Patients with acute urinary tract infection
- Patients with a history of pelvic fracture associated with SCI
- Patients using medications that may affect NDO (anticholinergic-sympathomimetic, etc.)
- Patients who have undergone another neuromodulation technique after injury
- Patients who have previously undergone pelvic radiation, bladder cancer, or other surgical procedures performed on the bladder that may affect bladder physiology will not be included in the study.
Ankara City Hospital BilkentStudy Central Contact
Contact: Zeynep S Güneş, +905545263535, [email protected]
1 Study Locations in 1 Countries
Çankaya
Ankara Bilkent City Hospital, Ankara, Çankaya, 06800, Turkey (Türkiye)
Zuhal Özişler, Contact, [email protected]
Recruiting