Image

NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

Recruiting
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

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.

Study details
    Bladder Dysfunction

NCT07019597

Daniel David Álamo Arce

24 June 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.