Actively Recruiting

Phase Not Applicable
All Genders
ID07019597

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

25

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 1 location

1

University of Valencia

Valencia, Spain, 46010

Actively Recruiting

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Research Team

R

Raquel I Medina-Ramírez, PhD. Physiotherapist

L

Laura FUENTES-APARICIO, PhD. Physical Therapy

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/37947583

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.

Chi-Wen Lo, Mei-Yi Wu, Stephen Shei-Dei Yang...

https://pubmed.ncbi.nlm.nih.gov/32085542

Prevalence and bother of lower urinary tract symptoms and overactive bladder in Poland, an Eastern European Study.

Mikolaj Przydacz, Tomasz Golabek, Przemyslaw Dudek...

https://pubmed.ncbi.nlm.nih.gov/33188254