NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation
ConditionBladder Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDaniel David Álamo Arce
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Presence of urinary fistula.
Infections in the last 12 months.
Haematuria during the trial period.
Pregnancy or plans to become pregnant during the study.
Trial design
Treatments tested in this trial
- Non-invasive neuromodulation NESA(NNG)
- Non-invasive Neuromodulation Posterior Tibial (NTPG)
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Daniel David Álamo Arce
Lead sponsor
University of Las Palmas de Gran Canaria
Sponsor institution
Source ClinicalTrials.gov