NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
Launched by DANIEL DAVID ÁLAMO ARCE · Jun 10, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two non-invasive treatments for overactive bladder (OAB), which is a condition that causes a sudden urge to urinate, often leading to frequent trips to the bathroom. The trial aims to compare NESA neuromodulation, a new treatment that helps regulate bladder control, with another method called transcutaneous posterior tibial stimulation. Both treatments will be accompanied by exercises and education to help improve the participants' quality of life, manage symptoms, and enhance their sleep.
To participate, individuals must be adult women aged 38 to 85 with a diagnosis of overactive bladder who have not found relief from previous treatments. Those interested will attend ten sessions over five weeks, during which their quality of life and symptoms will be assessed through questionnaires. Participants will receive detailed information about the trial and must provide written consent before joining. The study has been approved by an ethics committee, ensuring that it is conducted safely and responsibly.
Gender
ALL
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.
About Daniel David álamo Arce
Daniel David Álamo Arce is a dedicated clinical trial sponsor with a focus on advancing medical research and improving patient outcomes. With a strong background in clinical practice and a commitment to ethical standards, he oversees the design, implementation, and management of clinical trials across various therapeutic areas. His approach emphasizes collaboration with healthcare professionals and regulatory bodies to ensure compliance and the highest quality of data. Through his leadership, Daniel aims to facilitate innovative treatments and contribute to the body of knowledge in the medical field, ultimately enhancing the quality of care for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, , Spain
Patients applied
Trial Officials
Paloma Blasco-Sonora, Physical Therapy
Principal Investigator
University of Valencia
Laura FUENTES-APARICIO, PhD. Physical Therapy
Study Director
University of Valencia
Raquel Medina-Ramírez, PhD. Physical Therapy
Study Director
University of Las Palmas
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported