The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury

NCT07578532 | Recruiting

• 1 other identifier: 1-25-937
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, randomized clinical trial is to compare the efficacy and safety of transcutaneous sacral magnetic stimulation versus sacral electrical stimulation for detrusor overactivity in 40 male and female patients aged 18-65 with suprasacral Spinal Cord Injury (SCI) whose DOA is confirmed by urodynamics and is refractory to anticholinergic medication. The main question(s) aims to answer : Is there a difference between SMS and SES in their effect on objective urodynamic parameters, such as maximum detrusor pressure during filling and bladder compliance? Is there a difference between SMS and SES in reducing the frequency of incontinence episodes and improving the Neurogenic Bladder Dysfunction Score? Researchers will compare Sacral Magnetic Stimulation and Sacral Electrical Stimulation to see if there are differences in their effects on urodynamic measures, clinical symptoms, and patient satisfaction/discomfort. Participants will: Be randomly assigned to one of two intervention groups: Sacral Magnetic Stimulation or Sacral Electrical Stimulation. Receive 20 sessions of the assigned transcutaneous sacral stimulation technique (5 times a week for 20 minutes per session). Undergo a series of evaluations before and after the 20 treatment sessions, including: Urodynamic assessment (cystometry + EMG). Clinical assessments (3-day bladder diary, Neurogenic Bladder Dysfunction Score, Neurogenic Bowel Dysfunction Score, Spinal Cord Independence Measure - SCIM). Patient-reported outcomes (Treatment Satisfaction Level - Likert Scale, Treatment Discomfort Level - Visual Analog Scale)

Conditions

Spinal Cord Injuries (SCI); Detrusor Overactivity

Keywords

spinal cord injury; transcutenous sacral magnetic stimulation; transcutenous sacral electrical stimulation; detrusor overactivity

Outcome Measures

Primary Outcomes (3)

• Maximum Detrusor Pressure (Pdetmax) during Filling Phase measured by urodynamics

  The highest pressure reached by the detrusor muscle during the filling phase, indicating the risk for upper urinary tract damage

  Patients will be evaluated with urodynamic study on the first day after the treatment ends

• Bladder Compliance measured by multichannel urodynamics

  Calculated as the change in bladder volume divided by the change in detrusor pressure. Values \<20 ml/cmH2O are considered low compliance.

  Patients will be evaluated with urodynamic study on the first day after the treatment ends

• Presence of Detrusor Sphincter Dyssynergia

  Increase in sphincter EMG activity during a detrusor contraction, recorded as present (Yes) or absent (No)

  Patients will be evaluated with urodynamic study on the first day after the treatment ends

Secondary Outcomes (5)

• Neurogenic Bladder Dysfunction Score

  This measurement will be performed twice. 1. During the initial evaluation of the patient (before stimulation has begun) 2. At the end of the treatment

• Neurogenic Bowel Dysfunction Score

  1. During the initial evaluation of the patient (before stimulation has begun) 2. Right after the treatment

• Spinal Cord Independence Measure III (SCIM III)

  1. During the initial evaluation of the patient (before stimulation has begun) 2. At the end of the treatment

• likert scale

  At the end of the treatment

• Visual analog scale

  At the end of the treatment

Study Arms (2)

Transcutaneous sacral electrical stimulation

ACTIVE COMPARATOR

Suprasacral spinal cord injury patients receiving transcutaneous sacral electrical stimulation

Device: Transcutaneous Sacral Electrical Stimulation

Transcutaneous sacral magnetic stimulation

ACTIVE COMPARATOR

Suprasacral spinal cord injury patients receiving transcutaneous sacral magnetic stimulation

Device: Transcutaneous sacral magnetic stimulation

Interventions

Transcutaneous sacral magnetic stimulation DEVICE

The group to receive magnetic stimulation will be given a total of 1200 shots for 2 seconds with 28-second intervals, at a frequency of 10 Hz for 20 minutes, 5 times a week for 20 sessions, creating a feeling of contraction in the inner thigh or perineum, using the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device available at our hospital. For repetitive magnetic stimulation of the sacral roots, the patients will be placed in the prone position, and 8 coils with an outer diameter of 70 mm will be positioned on the midline of the sacrum to cover the bilateral third sacral neural foramina.

Transcutaneous sacral magnetic stimulation

Transcutaneous Sacral Electrical Stimulation DEVICE

Electrical stimulation will be applied symmetrically to both sides on the level determined to be over the S3 foramina by manual palpation of the sacrum, using 5x5 cm electrodes, and the current intensity will be increased until contraction is observed in the patient's external anal sphincter, at a current frequency of 20 Hz, pulse duration of 200 microseconds, 5 times a week for 20 minutes for 20 sessions.

Transcutaneous sacral electrical 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:

• years old Traumatic and non-traumatic suprasacral SCI; Detrusor overactivity confirmed by urodynamics (spontaneous and/or provocative detrusor contraction during the filling phase will be accepted as detrusor overactivity) Patients who have been receiving anticholinergic and/or sympathomimetic treatment for the last 3 months and whose pharmacological medical treatment dose has not been changed since the last urodynamic examination will be included in the study.

You may not qualify if:

• Patients with a cardiac pacemaker,
• Patients diagnosed with epilepsy,
• Patients with a metal implant within a 10 cm radius of the area where the treatment will be applied,
• Patients who have received botox injection to the bladder in the last 6 months,
• Patients who have received any neuromodulation technique in the last 6 months,
• Patients who have undergone surgical procedure for neurogenic bladder,
• Patients with another neurological disease that may affect neurogenic bladder (Parkinson's, polyneuropathy, neurodegenerative disease, cerebrovascular disease, etc.)
• Patients with acute urinary tract infection,
• Patients diagnosed with bladder outlet obstruction (urethral stricture, benign prostatic hyperplasia, etc.) will not be included in the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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

• Doherty S, Vanhoestenberghe A, Duffell L, Hamid R, Knight S. A Urodynamic Comparison of Neural Targets for Transcutaneous Electrical Stimulation to Acutely Suppress Detrusor Contractions Following Spinal Cord Injury. Front Neurosci. 2019 Dec 17;13:1360. doi: 10.3389/fnins.2019.01360. eCollection 2019.

  PMID: 31956301 RESULT

• Chen SF, Kuo HC. Will repeated botulinum toxin A improve detrusor overactivity and bladder compliance in patients with chronic spinal cord injury? Tzu Chi Med J. 2020 Jul 29;33(2):101-107. doi: 10.4103/tcmj.tcmj_77_20. eCollection 2021 Apr-Jun.

  PMID: 33912405 RESULT

• Panicker JN. Neurogenic Bladder: Epidemiology, Diagnosis, and Management. Semin Neurol. 2020 Oct;40(5):569-579. doi: 10.1055/s-0040-1713876. Epub 2020 Oct 16.

  PMID: 33065745 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

• Hamid R, Averbeck MA, Chiang H, Garcia A, Al Mousa RT, Oh SJ, Patel A, Plata M, Del Popolo G. Epidemiology and pathophysiology of neurogenic bladder after spinal cord injury. World J Urol. 2018 Oct;36(10):1517-1527. doi: 10.1007/s00345-018-2301-z. Epub 2018 May 11.

  PMID: 29752515 RESULT

• Lu J, Cheng B, Lin L, Yue S. Urodynamic findings in patients with complete and incomplete suprasacral spinal cord injury at different stages after injury. Ann Palliat Med. 2021 Mar;10(3):3171-3178. doi: 10.21037/apm-21-314.

  PMID: 33849102 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

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep YAKISIR

CONTACT

+905347278666; zeynepyaksr@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: May 11, 2026
• Study Start: March 26, 2025
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)