Non-invasive NESA Neuromodulation Versus Transcutaneous Posterior Tibial Nerve Stimulation for the Treatment of Overactive Bladder
Led by Daniel David Álamo Arce · Updated on 2025-06-13
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4 weeks
Total Duration
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What this Trial Is About
Overactive bladder (OAB) is a common condition causing urgency, frequent urination, and sometimes urge incontinence. Researchers are evaluating non-invasive neuromodulation techniques as alternative treatments for OAB patients who have not responded well to conventional therapies. This study aims to compare the effects of non-invasive NESA neuromodulation with posterior tibial nerve stimulation on quality of life, symptoms, discomfort, and sleep in adults with OAB.
The study involves 24 women aged 38 to 85 years who will undergo ten treatment sessions twice a week. One group will receive NESA neuromodulation using a device that emits very low frequency, intensity, and voltage currents through electrodes on gloves and anklets, combined with pelvic exercises and patient education. The other group will receive transcutaneous posterior tibial nerve stimulation using a TENS device with electrodes placed along the tibial nerve pathway, also combined with pelvic exercises and education.
Participants will be assessed before treatment, immediately after the ten sessions, and at two months post-treatment. Researchers will measure quality of life with the SF-36 questionnaire, sleep quality with the Pittsburgh questionnaire, urinary incontinence symptoms with the ICIQ-SF, bladder control with the B-SAQ, and patient satisfaction at follow-up. The study includes monitoring for safety and adherence, with all participants providing informed consent.
CONDITIONS
Brief Title
NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
Primary diagnosis of overactive bladder, regardless of previous active or alternative treatments
Patients who have had pharmacological treatments without adequate clinical response
Cognitive ability to participate and complete study questionnaires
Provided written informed consent
No contraindications for electrotherapy such as serious pacemaker use, pregnancy, internal bleeding, poor skin condition, or electricity phobia
You will not qualify if you...
Presence of urinary fistula
Infections within the last 12 months
Haematuria during the trial period
Pregnancy or plans to become pregnant during the study
Central or peripheral nervous system diseases like multiple sclerosis or Parkinson's disease
Uncontrolled diabetes
Treatment with Botox injections for the bladder currently or within the last year
Current treatment with or implanted interstim device
Bladder outlet obstruction
Urinary retention
Use of more than two antidepressants, multiple benzodiazepines, or antiepileptic drugs
Contraindications for electrotherapy treatment
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Approximately 2 weeks
Participants receive non-invasive neuromodulation treatment using either the NESA or posterior tibial nerve stimulation devices, combined with pelvic exercises and education.
Daily visits for treatment sessions during the intervention period
Follow-up
Duration - 2 months
Participants complete questionnaires and assessments immediately after treatment ends and again at two months to evaluate outcomes and satisfaction.
2 visits (in-person) for outcome assessments post-treatment
Improving Sleep Quality, Daytime Sleepiness, and Cognitive Function in Patients with Dementia by Therapeutic Exercise and NESA Neuromodulation: A Multicenter Clinical Trial.
Esther Teruel-Hernández, José Antonio López-Pina, Sonia Souto-Camba...
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.