Sacral and tibial nerve stimulation to improve bladder function after recent suprasacral spinal cord injury
Effectiveness of Transcutaneous Tibial and Sacral Nerve Stimulation in Preventing the Development of Detrusor Overactivity in Patients With Subacute Suprasacral Spinal Cord Injury
This trial will test whether noninvasive sacral or tibial nerve stimulation can prevent or reduce overactive bladder in adults within six months of a suprasacral spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ankara, Çankaya) |
| Trial ID | NCT07343583 on ClinicalTrials.gov |
What this trial studies
Adults with traumatic or non‑traumatic suprasacral spinal cord injury (within six months of injury and above T11) are randomly assigned to transcutaneous tibial nerve stimulation (TTNS), transcutaneous sacral nerve stimulation (TSNS), or standard care without neuromodulation. Intervention groups receive 15 sessions of noninvasive neuromodulation, with urodynamic evaluations used to measure detrusor activity and bladder pressures before and after the intervention period. The protocol compares the two stimulation sites to determine which, if either, better prevents development or progression of neurogenic detrusor overactivity in the subacute phase. Outcomes focus on objective urodynamic measures and clinically relevant bladder symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 with a suprasacral (above T11) spinal cord injury of less than six months' duration who do not have pacemakers, active urinary infection, other neurologic diseases affecting the bladder, prior pelvic radiation or bladder surgery, or medications that alter bladder function.
Not a fit: Patients with chronic (>6 months) or lower motor neuron spinal injuries, structural genitourinary abnormalities, active urinary tract infection, prior neuromodulation after injury, pacemakers, or other excluded conditions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, these noninvasive approaches could reduce urinary incontinence and high bladder storage pressures, lowering the risk of kidney damage and the need for medications or invasive procedures.
How similar studies have performed: Transcutaneous tibial nerve stimulation has shown benefit in some neurogenic and non‑neurogenic bladder disorders, while transcutaneous sacral stimulation is less well studied and comparative data in subacute SCI are currently lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ankara, Çankaya
- Ankara Bilkent City Hospital — Ankara, Çankaya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Zuhal Özişler, associate professor — Ankara City Hospital Bilkent
- Study coordinator: Zeynep S Güneş
- Email: gnszeynp19@gmail.com
- Phone: +905545263535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.