RecruitingNot ApplicableNCT07343583

Effects of Sacral and Tibial Stimulation on Bladder Function in Subacute 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

Sponsor

Ankara City Hospital Bilkent

Enrollment

45 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury Detrusor Overacitivity

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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

Exclusion Criteria8

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.

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Interventions

DEVICETranscutaneous 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. Stimulation will be applied in continuous mode at a frequency of 20 Hz and a pulse duration of 200 msec. The intensity will then be increased to the highest level tolerated by the patient, which will not cause lower extremity muscle spasm in patients with complete SCI and will not cause discomfort in the stimulation areas in patients with incomplete SCI. TTSS sessions will be administered 5 times per week, for a total of 15 sessions, each lasting 30 minutes.

DEVICETranscutaneous 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-minute intervals 5 times a week.