Sacral and tibial nerve stimulation to improve bladder function after recent suprasacral spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.