NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
Recruiting now · Not applicable
Conditions studied: Bladder Dysfunction
In brief
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.
Key facts
- Study ID
- NCT07019597
- Run by
- Daniel David Álamo Arce
- People needed
- 25
- Starts
- 2025-05-01
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2025-06-13
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University of Valencia — Valencia, Spain (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.