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

NCT07343583 | Recruiting

• 1 other identifier: 2-25-900
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury; Detrusor Overacitivity

Keywords

transcutaneous sacral stimulation; transcutaneous tibial stimulation; detrusor overactivity; neurogenic bowel dysfunction; subacute spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Comparison of urodynamic data in patients with subacute suprasacral spinal cord injury

  The primary outcome is the comparison of urodynamic parameters among three groups: tibial nerve stimulation, sacral stimulation, and control group without stimulation in patients with subacute suprasacral spinal cord injury

  A single urodynamic assessment is performed immediately after completion of the 3-week stimulation protocol (no later than 24 hours after the final session) and once for each patient.

Secondary Outcomes (3)

• Neurogenic Bladder Dysfunction Score

  This measurement will be performed twice. 1. During the initial evaluation of the patient (before stimulation has begun) 2. One month after the completion of urodynamic testing in patients who have completed stimulation

• Neurogenic Bowel Dysfunction Score

  This measurement will be performed twice. 1. During the initial evaluation of the patient (before stimulation has begun) 2. One month after the completion of urodynamic testing in patients who have completed stimulation

• Spinal Cord Independence Measure III (SCIM III)

  This measurement will be performed twice. 1. During the initial evaluation of the patient (before stimulation has begun) 2. One month after the completion of urodynamic testing in patients who have completed stimulation

Study Arms (3)

transcutaneous tibial nerve stimulation

ACTIVE COMPARATOR

Subacute suprasacral spinal cord injury patients receiving transcutaneous tibial nerve stimulation.

Device: Transcutaneous Tibial Nerve Stimulation

transcutaneous sacral nerve stimulation

ACTIVE COMPARATOR

Subacute suprasacral spinal cord injury patients receiving transcutaneous sacral nerve stimulation.

Device: Transcutaneous Sacral Nerve Stimulation

Control group

NO INTERVENTION

Data from patients who have not undergone any stimulation prior to urodynamics in the standard protocol will be used. Urodynamic results will be evaluated by comparing them between groups.

Interventions

Transcutaneous Tibial Nerve Stimulation DEVICE

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.

transcutaneous tibial nerve stimulation

Transcutaneous Sacral Nerve Stimulation DEVICE

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.

transcutaneous sacral nerve stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Fergany LA, Shaker H, Arafa M, Elbadry MS. Does sacral pulsed electromagnetic field therapy have a better effect than transcutaneous electrical nerve stimulation in patients with neurogenic overactive bladder? Arab J Urol. 2017 Mar 29;15(2):148-152. doi: 10.1016/j.aju.2017.01.007. eCollection 2017 Jun.

  PMID: 29071144 RESULT

• Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019.

  PMID: 30837835 RESULT

• Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, Rosenbluth JP, Presson AP, Myers JB; Neurogenic Bladder Research Group (NBRG.org). Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury. BMC Urol. 2018 Aug 29;18(1):72. doi: 10.1186/s12894-018-0383-y.

  PMID: 30157824 RESULT

• Sonmez R, Yildiz N, Alkan H. Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101486. doi: 10.1016/j.rehab.2021.101486. Epub 2021 Nov 11.

  PMID: 33429090 RESULT

• Yamanishi T, Kaga K, Fuse M, Shibata C, Uchiyama T. Neuromodulation for the Treatment of Lower Urinary Tract Symptoms. Low Urin Tract Symptoms. 2015 Sep;7(3):121-32. doi: 10.1111/luts.12087. Epub 2015 Feb 17.

  PMID: 26663726 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zuhal Özişler, associate professor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep S Güneş

CONTACT

+905545263535; gnszeynp19@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with subacute suprasacral spinal cord injury will be randomly assigned into three parallel groups. One group will receive tibial nerve stimulation, the second group will receive sacral nerve stimulation, and the control group will receive no stimulation. Urodynamic outcomes will be compared between the three groups after the intervention period. Functional and symptom-based questionnaires will be assessed before the intervention and after urodynamic evaluation, and both within-group and between-group comparisons will be performed.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 15, 2026
• Study Start: August 5, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)