Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07343583

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

Led by Ankara City Hospital Bilkent · Updated on 2026-01-15

45

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Spinal cord injury duration less than 6 months
  • Traumatic or non-traumatic suprasacral spinal cord injury
  • Injury located above the T11 vertebra
Not Eligible

You will not qualify if you...

  • Presence of a cardiac pacemaker
  • Other neurological diseases affecting neurogenic bladder (e.g., Parkinson's disease, polyneuropathy, neurodegenerative disease, cerebrovascular disease)
  • Structural abnormalities in the urinary system (e.g., pelvic floor dysfunction, benign prostatic hyperplasia)
  • Acute urinary tract infection
  • History of pelvic fracture related to spinal cord injury
  • Use of medications affecting neurogenic detrusor overactivity (e.g., anticholinergic-sympathomimetic drugs)
  • Previous neuromodulation treatment after injury
  • Prior pelvic radiation, bladder cancer, or bladder surgery affecting bladder function

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye), 06800

Actively Recruiting

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Research Team

Z

Zeynep S Güneş

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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