NESA neuromodulation versus posterior tibial nerve stimulation for overactive bladder
Non-invasive NESA Neuromodulation Versus Transcutaneous Posterior Tibial Nerve Stimulation for the Treatment of Overactive Bladder
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Sex | All |
| Sponsor | University of Las Palmas de Gran Canaria Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT07019597 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Valencia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.