Spinal Cord InjuryNCT07343583
Effects of Sacral and Tibial Stimulation on Bladder Function in Subacute Suprasacral Spinal Cord Injury
A study testing Transcutaneous Tibial Nerve Stimulation and Transcutaneous Sacral Nerve Stimulation in people with Spinal Cord Injury and Detrusor Overacitivity, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Detrusor Overacitivity
- What is being tested?
- Transcutaneous Tibial Nerve Stimulation and Transcutaneous Sacral Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18-65 years of age
- Injury duration <6 months
- Traumatic and non-traumatic SCI;
- Patients with spinal cord injury above T11
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
Zuhal Özişler, zuhalozisler@gmail.com
About this study
Official title: Effectiveness of Transcutaneous Tibial and Sacral Nerve Stimulation in Preventing the Development of Detrusor Overactivity in Patients With Subacute Suprasacral Spinal Cord Injury
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.
Read more
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.
Read the detailed description
Neurogenic detrusor overactivity (NDO) is a common consequence of suprasacral spinal cord injury (SCI) and represents a major risk factor for urinary incontinence and upper urinary tract deterioration. During the subacute phase following SCI, maladaptive spinal reflex pathways associated with detrusor overactivity are still evolving. Interventions applied during this period may influence the development and severity of long-term bladder dysfunction.
Non-invasive neuromodulation techniques have been shown to modulate afferent neural pathways involved in lower urinary tract control. Transcutaneous tibial neurostimulation (TTNS) has demonstrated efficacy in both neurogenic and non-neurogenic bladder dysfunction, while evidence regarding transcutaneous sacral neurostimulation (TSNS) remains limited. Comparative data evaluating these two transcutaneous approaches in subacute SCI-related NDO are lacking.
This prospective randomized comparative study is designed to evaluate the effects of TTNS and TSNS applied during the subacute phase of suprasacral SCI on the prevention of NDO development. Adult patients with traumatic or non-traumatic suprasacral SCI within six months of injury will be enrolled and randomly assigned to one of three groups: TTNS, TSNS, or a control group receiving standard care without neuromodulation prior to urodynamic evaluation.
Participants in the intervention groups will receive non-invasive transcutaneous neuromodulation administered 15 sessions. Following completion of sessions, all groups will undergo standardized urodynamic assessment in accordance with International Continence Society (ICS) recommendations. Urodynamic parameters including maximal detrusor pressure during filling, bladder compliance, and maximal cystometric capacity, will be evaluated and compared between groups.
In addition to urodynamic outcomes, functional status and symptom severity related to neurogenic bladder and neurogenic bowel dysfunction will be assessed using validated clinical scales. A secondary analysis will examine the impact of TTNS and TSNS on the severity of neurogenic bowel dysfunction during the subacute SCI period.
This study aims to clarify the role of early, non-invasive neuromodulation in modulating bladder and bowel dysfunction following suprasacral SCI. The findings are expected to contribute to evidence-based decision-making regarding early intervention strategies and to support the development of standardized transcutaneous neuromodulation protocols in SCI rehabilitation.
- Conditions
- Spinal Cord Injury, Detrusor Overacitivity
- Being tested
- Transcutaneous Tibial Nerve Stimulation, Transcutaneous Sacral Nerve Stimulation
- Keywords
- transcutaneous sacral stimulation, transcutaneous tibial stimulation, detrusor overactivity, neurogenic bowel dysfunction, subacute spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Tibial Nerve StimulationDevice
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 Sacral Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous tibial nerve stimulation | Active comparator | Subacute suprasacral spinal cord injury patients receiving transcutaneous tibial nerve stimulation. Receives: Device: Transcutaneous Tibial Nerve Stimulation |
| transcutaneous sacral nerve stimulation | Active comparator | Subacute suprasacral spinal cord injury patients receiving transcutaneous sacral nerve stimulation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
It is a score specifically developed to assess symptoms and outcomes associated with neurogenic bladder dysfunction. It is a 24-item questionnaire (0-74 points). The higher the score, the greater the severity of symptoms. Its validity and reliability in Turkish have been demonstrated.
Measured: 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
It was developed to assess neurogenic bowel dysfunction in patients with spinal cord injury. It consists of 10 items related to the impaired quality of life caused by bowel symptoms. Its validity and reliability in Turkish have been demonstrated.
Measured: 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)
It is specifically designed to cover all aspects related to individuals with SCI, including self-care ability, respiratory and sphincter management, and daily mobility. SCIM results reflect the independence of individuals with SCI; a higher score indicates that very little assistance or fewer helpers are needed to complete basic daily living and life support activities.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start5 Aug 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zuhal Özişler, associate professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343583
- Sponsor's protocol ID
- 2-25-900
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29071144Stampas 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.
PubMed 30837835Redshaw 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.
PubMed 30157824Sonmez 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.
PubMed 33429090Yamanishi 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.
PubMed 26663726
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcutaneous Tibial and Sacral Nerve Stimulation in Preventing the Development of Detrusor Overactivity in Patients With Subacute Suprasacral Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07343583
- Acronym / sponsor ID
- 2-25-900
- Conditions
- Spinal Cord Injury, Detrusor Overacitivity
- Keywords
- transcutaneous sacral stimulation, transcutaneous tibial stimulation, detrusor overactivity, neurogenic bowel dysfunction, subacute spinal cord injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurogenic detrusor overactivity (NDO) is a common consequence of suprasacral spinal cord injury (SCI) and represents a major risk factor for urinary incontinence and upper urinary tract deterioration. During the subacute phase following SCI, maladaptive spinal reflex pathways associated with detrusor overactivity are still evolving. Interventions applied during this period may influence the development and severity of long-term bladder dysfunction.
Non-invasive neuromodulation techniques have been shown to modulate afferent neural pathways involved in lower urinary tract control. Transcutaneous tibial neurostimulation (TTNS) has demonstrated efficacy in both neurogenic and non-neurogenic bladder dysfunction, while evidence regarding transcutaneous sacral neurostimulation (TSNS) remains limited. Comparative data evaluating these two transcutaneous approaches in subacute SCI-related NDO are lacking.
This prospective randomized comparative study is designed to evaluate the effects of TTNS and TSNS applied during the subacute phase of suprasacral SCI on the prevention of NDO development. Adult patients with traumatic or non-traumatic suprasacral SCI within six months of injury will be enrolled and randomly assigned to one of three groups: TTNS, TSNS, or a control group receiving standard care without neuromodulation prior to urodynamic evaluation.
Participants in the intervention groups will receive non-invasive transcutaneous neuromodulation administered 15 sessions. Following completion of sessions, all groups will undergo standardized urodynamic assessment in accordance with International Continence Society (ICS) recommendations. Urodynamic parameters including maximal detrusor pressure during filling, bladder compliance, and maximal cystometric capacity, will be evaluated and compared between groups.
In addition to urodynamic outcomes, functional status and symptom severity related to neurogenic bladder and neurogenic bowel dysfunction will be assessed using validated clinical scales. A secondary analysis will examine the impact of TTNS and TSNS on the severity of neurogenic bowel dysfunction during the subacute SCI period.
This study aims to clarify the role of early, non-invasive neuromodulation in modulating bladder and bowel dysfunction following suprasacral SCI. The findings are expected to contribute to evidence-based decision-making regarding early intervention strategies and to support the development of standardized transcutaneous neuromodulation protocols in SCI rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| transcutaneous tibial nerve stimulation | Active comparator | Device: Transcutaneous Tibial Nerve StimulationSubacute suprasacral spinal cord injury patients receiving transcutaneous tibial nerve stimulation. |
| transcutaneous sacral nerve stimulation | Active comparator | Device: Transcutaneous Sacral Nerve StimulationSubacute suprasacral spinal cord injury patients receiving 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18-65 years of age
- Injury duration <6 months
- Traumatic and non-traumatic SCI;
- Patients with spinal cord injury above T11
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Tibial Nerve StimulationFor 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. | Device | transcutaneous tibial nerve stimulation |
| Transcutaneous Sacral Nerve StimulationFor 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. | Device | transcutaneous sacral nerve stimulation |
Primary outcome
Comparison of urodynamic data in patients with subacute suprasacral spinal cord injury
Time frame: 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.
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
3 secondary outcomes
Neurogenic Bladder Dysfunction Score
Time frame: 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
Time frame: 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)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 29071144Fergany 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.
- Results publication: PubMed 30837835Stampas 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.
- Results publication: PubMed 30157824Redshaw 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.
- Results publication: PubMed 33429090Sonmez 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.
- Results publication: PubMed 26663726Yamanishi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuhal Özişler, associate professor principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Tibial Nerve Stimulation and Transcutaneous Sacral Nerve Stimulation in people with Spinal Cord Injury and Detrusor Overacitivity, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep S Güneş (+905545263535, gnszeynp19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of urodynamic data in patients with subacute suprasacral spinal cord injury (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07343583, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.