NCT07019597 NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
| NCT ID | NCT07019597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daniel David Álamo Arce |
| Condition | Bladder Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-05-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Contact & Investigator
Paloma Blasco-Sonora, Physical Therapy
PRINCIPAL INVESTIGATOR
University of Valencia
Frequently Asked Questions
Who can join the NCT07019597 clinical trial?
This trial is open to participants of all sexes, studying Bladder Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07019597 currently recruiting?
Yes, NCT07019597 is actively recruiting participants. Contact the research team at raquel.medina@ulpgc.es for enrollment information.
Where is the NCT07019597 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT07019597 clinical trial?
NCT07019597 is sponsored by Daniel David Álamo Arce. The principal investigator is Paloma Blasco-Sonora, Physical Therapy at University of Valencia. The trial plans to enroll 25 participants.