Effects of Sacral and Tibial Stimulation on Bladder Function in Subacute Suprasacral Spinal Cord Injury

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injury, Detrusor Overacitivity

In brief

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.

Key facts

Study ID: NCT07343583
Run by: Ankara City Hospital Bilkent
People needed: 45
Starts: 2025-08-05
Expected to finish: 2026-04-01
Last updated by the study team: 2026-01-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥18-65 years of age
Injury duration <6 months
Traumatic and non-traumatic SCI;
Patients with spinal cord injury above T11

You may not qualify if…

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.

Where it is running

Ankara Bilkent City Hospital — Ankara, Çankaya, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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