NCT07343583 Effects of Sacral and Tibial Stimulation on Bladder Function in Subacute Suprasacral Spinal Cord Injury
| NCT ID | NCT07343583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara City Hospital Bilkent |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-08-05 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 treatments are considered first-line therapy for NDO; however, adequate control may not be achieved in all patients, and treatment tolerance may be limited. Non-invasive neuromodulation techniques have emerged as alternative or adjunctive approaches for managing lower urinary tract dysfunction, but evidence regarding their effectiveness in SCI-related NDO-especially when applied during the subacute period-remains limited. This prospective randomized comparative study aims to evaluate and compare the effectiveness of transcutaneous sacral neurostimulation (TSNS) and transcutaneous tibial neurostimulation (TTNS) applied during the subacute phase of suprasacral SCI in preventing the development of neurogenic detrusor overactivity. A secondary objective is to assess the effects of these interventions on the severity of neurogenic bowel dysfunction. Eligible adult patients with subacute suprasacral SCI will be randomized into three groups: TTNS, TSNS, or a control group receiving standard care without neuromodulation prior to urodynamic assessment. Urodynamic parameters including detrusor pressure, bladder compliance, and maximal cystometric capacity, will be compared between groups. Functional outcomes and symptom severity related to neurogenic bladder and bowel dysfunction will also be evaluated. By investigating non-invasive neuromodulation strategies applied early after SCI, this study aims to contribute evidence regarding the prevention of NDO development and to support the optimization of neuromodulation use in clinical practice for individuals with suprasacral SCI.
Eligibility Criteria
Inclusion Criteria: 1. ≥18-65 years of age 2. Injury duration \<6 months 3. Traumatic and non-traumatic SCI; 4. Patients with spinal cord injury above T11 Exclusion Criteria: 1. Patients with a cardiac pacemaker 2. Patients with other neurological diseases that may affect neurogenic bladder (Parkinson's disease, polyneuropathy, neurodegenerative disease, cerebrovascular disease, etc.) 3. Patients with structural abnormalities in the genitourinary system (pelvic floor dysfunction, BPH, etc.) 4. Patients with acute urinary tract infection 5. Patients with a history of pelvic fracture associated with SCI 6. Patients using medications that may affect NDO (anticholinergic-sympathomimetic, etc.) 7. Patients who have undergone another neuromodulation technique after injury 8. 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.
Contact & Investigator
Zuhal Özişler, associate professor
PRINCIPAL INVESTIGATOR
Ankara City Hospital Bilkent
Frequently Asked Questions
Who can join the NCT07343583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07343583 currently recruiting?
Yes, NCT07343583 is actively recruiting participants. Contact the research team at gnszeynp19@gmail.com for enrollment information.
Where is the NCT07343583 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07343583 clinical trial?
NCT07343583 is sponsored by Ankara City Hospital Bilkent. The principal investigator is Zuhal Özişler, associate professor at Ankara City Hospital Bilkent. The trial plans to enroll 45 participants.