Bladder DysfunctionNesaTibialNCT07019597
NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
A study testing Non-invasive neuromodulation NESA(NNG) and Non-invasive Neuromodulation Posterior Tibial (NTPG) in people with Bladder Dysfunction, run by Daniel David Álamo Arce at 1 site in Spain.
Trial summary
Introduction: Overactive bladder (OAB) is a common condition characterized by urinary urgency, frequency, and, in some cases, urge incontinence. Non-invasive neuromodulation has emerged as an effective therapeutic option by modulating the neural pathways involved in bladder control. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Dysfunction
- What is being tested?
- Non-invasive neuromodulation NESA(NNG) and Non-invasive Neuromodulation Posterior Tibial (NTPG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2025to 1 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Minimum criteria for a primary diagnosis of overactive bladder who have or have not received active/alternative treatments for this pathology.
- Patients with previous pharmacological treatments that have not obtained an adequate clinical response.
- Patients whose cognitive abilities are competent to participate in the study and are able to complete the study questionnaires and have given written consent to participate in the study.
- Without further contraindications for electrotherapy treatment such as serious use of pacemakers, pregnancy, internal bleeding, poor skin condition (ulcerations, wounds...) and/or phobia of electricity.
Who cannot join
- Presence of urinary fistula.
- Infections in the last 12 months.
- Haematuria during the trial period.
- Pregnancy or plans to become pregnant during the study.
- Pathology of the central or peripheral nervous system (multiple sclerosis, Parkinson's disease, etc.).
- Uncontrolled diabetes.
Show all 12Show fewer
- Currently treated with Botox injections for the bladder or within the last year.
- Current treatment with interstim or currently implanted interstim device.
- Bladder outlet obstruction.
- Urinary retention.
- Treatment with more than two antidepressants and/or multiple benzodiazepines, as well as antiepileptics.
- Contraindications for electrotherapy treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, 46010
Laura Fuentes-Aparicio, PhD. Physical Therapy, 699682391 ext. 0034, Laura.Fuentes@uv.es
Paloma Blasco Sonora, Physical Therapy, 656438815 ext. 0034
About this study
Official title: Non-invasive NESA Neuromodulation Versus Transcutaneous Posterior Tibial Nerve Stimulation for the Treatment of Overactive Bladder
Introduction: Overactive bladder (OAB) is a common condition characterized by urinary urgency, frequency, and, in some cases, urge incontinence. Non-invasive neuromodulation has emerged as an effective therapeutic option by modulating the neural pathways involved in bladder control. This approach offers a promising alternative for patients who do not respond to conventional treatments.
Objectives: To evaluate the effect of non-invasive NESA neuromodulation compared to posterior tibial stimulation in patients with overactive bladder.
Read more
compared to posterior tibial stimulation, with same-day exercises and patient education on quality of life, symptoms, discomfort and sleep.
day of the session and patient education on quality of life, symptoms, discomfort and sleep.
Methods: Twenty-four patients (24 women), aged 38-85 years with overactive bladder will be included in this experimental clinical trial study. Each patient will attend ten sessions two days a week. Patient life quality will be measured using SF-36, sleep quality with the Pittsburgh questionnaire, perception of urinari incontinence (UI) symptoms and patient quality of life with the ICIQ-SF questionnaire. All these variables will be measured before, immediately after the ten sessions and at two months after the end of treatment.
Ethic: The study was approved by the ethics committee of the University of Valencia, and all participants will be given an informed consent form.
- Conditions
- Bladder Dysfunction
- Being tested
- Non-invasive neuromodulation NESA(NNG), Non-invasive Neuromodulation Posterior Tibial (NTPG)
- Keywords
- overactive bladder, Transcutaneous neuromodulation, Nesa Non-Invasive Neuromodulation, Posterior tibial nerve stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive neuromodulation NESA(NNG)Device
Also called NESA neuromodulation, NESA ultra low currents
NESA is a non-invasive monitoring device, which emits low frequency (1.3-14.28 Hz, depending on the programme), low intensity (0.1-0.9 mA), low voltage (±3 V) ultra low currents, and therefore imperceptible to the patient. It is based on neuromodulation of the autonomic nervous system.
Non-invasive Neuromodulation Posterior Tibial (NTPG)Device
Also called NEUROTRAC MYOPLUS PRO
NTPG is an electrotherapy using a device called NEUROTRAC MYOPLUS PRO (brand name) to perform non-invasive TENS-type electrotherapy with biphasic currents.
| Study group | Role | What they receive |
|---|---|---|
| Group1: Non-invasive neuromodulation NESA (NNG group) | Experimental | Group 1: Non-invasive NESA® Neuromodulation (NNG) using NESA (Applied superficial stimulation, acronym in spanish) device with same-day exercise and education by providing common, non-individualised written instructions, such as dietary and social advice.
NNG was performed with the patient supine, using NESA technology with gloves and anklets, with a total of 24 electrodes plus a directional electrode for global neuromodulation; NESA is a non-invasive monitoring device which emits ultra low frequency currents (1.3-14.28 Hz, depending on the programme), low intensity (0.1-0.9 mA), and low voltage (±3 V) and therefore imperceptible to the patient. Each day a different programme was applied. On the first three days, programme 1 (P1) 15 min, programme 2 (P2) 15 min and programme 7 (P7) 30 min were applied. From the fourth to the sixth day, P2 30 min and P7 30 min were applied, finishing the rest of the days with P3 30 min and P7 30 min. At the same time pelvic exercises were performed. Receives: Device: Non-invasive neuromodulation NESA(NNG) |
| Group 2: Non Invasive Posterior Tibial Neuromodulation (NTPG) | Active comparator | Group 2: Non-invasive posterior tibial neuromodulation (NTPG) with same-day exercises and education through common, non-individualised written instructions.
NTPG was performed by posterior tibial application plus pelvic exercises (same day of treatment) and advice, with the patient supine, using NEUROTRAC MYOPLUS PRO (brand name of the tibial stimulation device) to perform TENS (transcutaneous electric nerve stimulation) for 30 minutes. An electric current with a frequency of 10 Hz and pulse duration of 200μs was applied. The intensity was adjusted according to the patient's tolerance, with thumb flexion perceptible to visual inspection by the therapist. Two 50 x 50 millimeters electrodes were placed along the posterior tibial nerve pathway, one on the sole of the foot and the other near the medial malleolus on one leg. Receives: Device: Non-invasive Neuromodulation Posterior Tibial (NTPG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 questionnaire
The SF-36 is a 36-question survey that assesses health-related quality of life, measuring eight key domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. It's a widely used tool in clinical practice and research for evaluating health status and assessing the impact of interventions.
Measured: Before treatment, immediately after the treatment is finished and at two months later (follow-up)
Secondary outcomes (4)
Pittsburgh questionnaire
Sleep quality using the Pittsburgh questionnaire, consisting of 19 items that analyse 7 different components of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction). Each item is scored from 0 to 3. The total score of the scale ranges from 0 to 21 points where the lower end represents good sleep quality, and the upper end represents poor sleep quality
Measured: Sleep quality was assessed before, immediately after and at two months
ICIQ-UI Short Form
Perception of frequency, severity of urinary incontinence (UI) and patient quality of life were assessed using the International Consultation on Incontinence Questionnaire (ICIQ-SF) validated questionnaire, where the individual's daily experience of urination and incontinence is answered with three scored items and one unmarked self-diagnostic item.
Measured: ICIQ-SF was assessed before treatment, immediately after the treatment is finished and at two months later (follow-up)
Bladder Control Self-Assessment Questionnaire (B-SAQ)
Bladder symptoms and discomfort were assessed using the Bladder Control Self-Assessment Questionnaire (B-SAQ), a validated questionnaire consisting of 8 questions grouped into two scales, each with a scale of 0 to 3 points, giving a maximum score of 24 points (12 in each group).
Measured: Before treatment, immediately after the treatment is finished and at two months later (follow-up)
Personal satisfaction of patients
After two months they were asked about their satisfaction with the treatment received (numerical scale from 0 not satisfied -10 very satisfied), whether they continued to do the exercises and whether they had any side effects after the treatment.
Measured: In the follow-up (two month later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 May 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind, randomised controlled trial was conducted.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel David Álamo Arce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel David Álamo Arce, University of Las Palmas de Gran Canaria
- Investigators
- Paloma Blasco-Sonora, Physical Therapy, Principal investigator, University of ValenciaLaura FUENTES-APARICIO, PhD. Physical Therapy, Study director, University of ValenciaRaquel Medina-Ramírez, PhD. Physical Therapy, Study director, University of Las Palmas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019597
- Sponsor's protocol ID
- NesaTibial
- Acronym
- NesaTibial
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to be shared
Publications
Teruel-Hernandez E, Lopez-Pina JA, Souto-Camba S, Baez-Suarez A, Medina-Ramirez R, Gomez-Conesa A. Improving Sleep Quality, Daytime Sleepiness, and Cognitive Function in Patients with Dementia by Therapeutic Exercise and NESA Neuromodulation: A Multicenter Clinical Trial. Int J Environ Res Public Health. 2023 Nov 6;20(21):7027. doi: 10.3390/ijerph20217027.
PubMed 37947583Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Lo CW, Wu MY, Yang SS, Jaw FS, Chang SJ. Comparing the Efficacy of OnabotulinumtoxinA, Sacral Neuromodulation, and Peripheral Tibial Nerve Stimulation as Third Line Treatment for the Management of Overactive Bladder Symptoms in Adults: Systematic Review and Network Meta-Analysis. Toxins (Basel). 2020 Feb 18;12(2):128. doi: 10.3390/toxins12020128.
PubMed 32085542Przydacz M, Golabek T, Dudek P, Lipinski M, Chlosta P. Prevalence and bother of lower urinary tract symptoms and overactive bladder in Poland, an Eastern European Study. Sci Rep. 2020 Nov 13;10(1):19819. doi: 10.1038/s41598-020-76846-0.
PubMed 33188254
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive NESA Neuromodulation Versus Transcutaneous Posterior Tibial Nerve Stimulation for the Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT07019597
- Acronym / sponsor ID
- NesaTibial / NesaTibial
- Conditions
- Bladder Dysfunction
- Keywords
- overactive bladder, Transcutaneous neuromodulation, Nesa Non-Invasive Neuromodulation, Posterior tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Daniel David Álamo ArceUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 Jun 2025 (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.
Introduction: Overactive bladder (OAB) is a common condition characterized by urinary urgency, frequency, and, in some cases, urge incontinence. Non-invasive neuromodulation has emerged as an effective therapeutic option by modulating the neural pathways involved in bladder control. This approach offers a promising alternative for patients who do not respond to conventional treatments.
Objectives: To evaluate the effect of non-invasive NESA neuromodulation compared to posterior tibial stimulation in patients with overactive bladder.
compared to posterior tibial stimulation, with same-day exercises and patient education on quality of life, symptoms, discomfort and sleep.
day of the session and patient education on quality of life, symptoms, discomfort and sleep.
Methods: Twenty-four patients (24 women), aged 38-85 years with overactive bladder will be included in this experimental clinical trial study. Each patient will attend ten sessions two days a week. Patient life quality will be measured using SF-36, sleep quality with the Pittsburgh questionnaire, perception of urinari incontinence (UI) symptoms and patient quality of life with the ICIQ-SF questionnaire. All these variables will be measured before, immediately after the ten sessions and at two months after the end of treatment.
Ethic: The study was approved by the ethics committee of the University of Valencia, and all participants will be given an informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blind, randomised controlled trial was conducted.
| Arm | Type | Receives |
|---|---|---|
| Group1: Non-invasive neuromodulation NESA (NNG group) | Experimental | Device: Non-invasive neuromodulation NESA(NNG)Group 1: Non-invasive NESA® Neuromodulation (NNG) using NESA (Applied superficial stimulation, acronym in spanish) device with same-day exercise and education by providing common, non-individualised written instructions, such as dietary and social advice. NNG was performed with the patient supine, using NESA technology with gloves and anklets, with a total of 24 electrodes plus a directional electrode for global neuromodulation; NESA is a non-invasive monitoring device which emits ultra low frequency currents (1.3-14.28 Hz, depending on the programme), low intensity (0.1-0.9 mA), and low voltage (±3 V) and therefore imperceptible to the patient. Each day a different programme was applied. On the first three days, programme 1 (P1) 15 min, programme 2 (P2) 15 min and programme 7 (P7) 30 min were applied. From the fourth to the sixth day, P2 30 min and P7 30 min were applied, finishing the rest of the days with P3 30 min and P7 30 min. At the same time pelvic exercises were performed. |
| Group 2: Non Invasive Posterior Tibial Neuromodulation (NTPG) | Active comparator | Device: Non-invasive Neuromodulation Posterior Tibial (NTPG)Group 2: Non-invasive posterior tibial neuromodulation (NTPG) with same-day exercises and education through common, non-individualised written instructions. NTPG was performed by posterior tibial application plus pelvic exercises (same day of treatment) and advice, with the patient supine, using NEUROTRAC MYOPLUS PRO (brand name of the tibial stimulation device) to perform TENS (transcutaneous electric nerve stimulation) for 30 minutes. An electric current with a frequency of 10 Hz and pulse duration of 200μs was applied. The intensity was adjusted according to the patient's tolerance, with thumb flexion perceptible to visual inspection by the therapist. Two 50 x 50 millimeters electrodes were placed along the posterior tibial nerve pathway, one on the sole of the foot and the other near the medial malleolus on one leg. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum criteria for a primary diagnosis of overactive bladder who have or have not received active/alternative treatments for this pathology.
- Patients with previous pharmacological treatments that have not obtained an adequate clinical response.
- Patients whose cognitive abilities are competent to participate in the study and are able to complete the study questionnaires and have given written consent to participate in the study.
- Without further contraindications for electrotherapy treatment such as serious use of pacemakers, pregnancy, internal bleeding, poor skin condition (ulcerations, wounds...) and/or phobia of electricity.
Key exclusion criteria (12 listed)
- Presence of urinary fistula.
- Infections in the last 12 months.
- Haematuria during the trial period.
- Pregnancy or plans to become pregnant during the study.
- Pathology of the central or peripheral nervous system (multiple sclerosis, Parkinson's disease, etc.).
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 |
|---|---|---|
| Non-invasive neuromodulation NESA(NNG)Also: NESA neuromodulation, NESA ultra low currentsNESA is a non-invasive monitoring device, which emits low frequency (1.3-14.28 Hz, depending on the programme), low intensity (0.1-0.9 mA), low voltage (±3 V) ultra low currents, and therefore imperceptible to the patient. It is based on neuromodulation of the autonomic nervous system. | Device | Group1: Non-invasive neuromodulation NESA (NNG group) |
| Non-invasive Neuromodulation Posterior Tibial (NTPG)Also: NEUROTRAC MYOPLUS PRONTPG is an electrotherapy using a device called NEUROTRAC MYOPLUS PRO (brand name) to perform non-invasive TENS-type electrotherapy with biphasic currents. | Device | Group 2: Non Invasive Posterior Tibial Neuromodulation (NTPG) |
Primary outcome
SF-36 questionnaire
Time frame: Before treatment, immediately after the treatment is finished and at two months later (follow-up)
The SF-36 is a 36-question survey that assesses health-related quality of life, measuring eight key domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. It's a widely used tool in clinical practice and research for evaluating health status and assessing the impact of interventions.
4 secondary outcomes
Pittsburgh questionnaire
Time frame: Sleep quality was assessed before, immediately after and at two months
ICIQ-UI Short Form
Time frame: ICIQ-SF was assessed before treatment, immediately after the treatment is finished and at two months later (follow-up)
Bladder Control Self-Assessment Questionnaire (B-SAQ)
Time frame: Before treatment, immediately after the treatment is finished and at two months later (follow-up)
Personal satisfaction of patients
Time frame: In the follow-up (two month later)
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 13 Jun 2025.
- Background: PubMed 37947583Teruel-Hernandez E, Lopez-Pina JA, Souto-Camba S, Baez-Suarez A, Medina-Ramirez R, Gomez-Conesa A. Improving Sleep Quality, Daytime Sleepiness, and Cognitive Function in Patients with Dementia by Therapeutic Exercise and NESA Neuromodulation: A Multicenter Clinical Trial. Int J Environ Res Public Health. 2023 Nov 6;20(21):7027. doi: 10.3390/ijerph20217027.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 32085542Lo CW, Wu MY, Yang SS, Jaw FS, Chang SJ. Comparing the Efficacy of OnabotulinumtoxinA, Sacral Neuromodulation, and Peripheral Tibial Nerve Stimulation as Third Line Treatment for the Management of Overactive Bladder Symptoms in Adults: Systematic Review and Network Meta-Analysis. Toxins (Basel). 2020 Feb 18;12(2):128. doi: 10.3390/toxins12020128.
- Background: PubMed 33188254Przydacz M, Golabek T, Dudek P, Lipinski M, Chlosta P. Prevalence and bother of lower urinary tract symptoms and overactive bladder in Poland, an Eastern European Study. Sci Rep. 2020 Nov 13;10(1):19819. doi: 10.1038/s41598-020-76846-0.
- Individual participant dataSharing planned: No. Not to be shared
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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.
Paloma Blasco-Sonora, Physical Therapy principal investigator
University of Valencia
Laura FUENTES-APARICIO, PhD. Physical Therapy study director
University of Valencia
Raquel Medina-Ramírez, PhD. Physical Therapy study director
University of Las Palmas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive neuromodulation NESA(NNG) and Non-invasive Neuromodulation Posterior Tibial (NTPG) in people with Bladder Dysfunction, run by Daniel David Álamo Arce at 1 site in Spain.
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 12 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 13 Jun 2025. 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 Spain. 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 Raquel I Medina-Ramírez, PhD. Physiotherapist (0034 665265685 ext. 0034, raquel.medina@ulpgc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 questionnaire (time frame: Before treatment, immediately after the treatment is finished and at two months later (follow-up)). 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 NCT07019597, which also lists 4 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 13 Jun 2025.