NESA neuromodulation versus posterior tibial nerve stimulation for overactive bladder
Official title: Non-invasive NESA Neuromodulation Versus Transcutaneous Posterior Tibial Nerve Stimulation for the Treatment of Overactive Bladder
Run by University of Las Palmas de Gran Canaria · NCT07019597 · Data updated 2026-11-12
This project will try NESA non-invasive neuromodulation versus posterior tibial nerve stimulation to see which better reduces urgency, frequency, and leakage in adult women with overactive bladder.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Las Palmas de Gran Canaria Academic / other |
| Locations | 1 site (Valencia) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | August 1, 2025 |
| Study ends | September 1, 2025 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT07019597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women with overactive bladder (including those who did not respond adequately to medication), able to attend twice-weekly sessions, and who have no contraindications to external electrotherapy.
✕Probably not a fit
Patients with pacemakers, pregnancy, recent infections, urinary fistula, significant neurological disease, uncontrolled diabetes, or other contraindications to electrotherapy are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Twenty-four women aged 38–85 with overactive bladder will receive ten sessions of non-invasive neuromodulation delivered twice weekly, with participants assigned to either NESA neuromodulation or transcutaneous posterior tibial nerve stimulation. Each session includes same-day exercises and patient education, and outcomes collected will include symptom scores, quality of life, discomfort, and sleep measures. The interventions are applied externally and exclude patients with contraindications such as pacemakers, pregnancy, recent infections, or certain neurological conditions. The study will compare changes over the treatment course to determine which non-invasive approach produces greater symptom and quality-of-life improvements.
Why it matters
Potential benefit: If successful, the intervention could offer a non-drug, non-surgical option that reduces urgency and incontinence and improves sleep and quality of life.
How similar studies have gone: Posterior tibial nerve stimulation has shown symptom improvement in prior studies for overactive bladder, while NESA non-invasive neuromodulation is comparatively less well-studied for this condition.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University of Valencia
Valencia, Spain Recruiting
Study contacts
- Principal investigator: Paloma Blasco-Sonora, Physical Therapy — University of Valencia
- Study coordinator: Raquel I Medina-Ramírez, PhD. Physiotherapist
- Email: raquel.medina@ulpgc.es
- Phone: 0034 665265685
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.