NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

N/ARecruitingNCT07019597

Daniel David Álamo Arce25 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bladder Dysfunction

Interventions

Non-invasive neuromodulation NESA(NNG)DEVICE

NESA is a non-invasive monitoring device, which emits low frequency (1.3-14.28 Hz, depending on the programme), low intensity (0.1-0.9 mA), low voltage (±3 V) ultra low currents, and therefore imperceptible to the patient. It is based on neuromodulation of the autonomic nervous system.

Non-invasive Neuromodulation Posterior Tibial (NTPG)DEVICE

NTPG is an electrotherapy using a device called NEUROTRAC MYOPLUS PRO (brand name) to perform non-invasive TENS-type electrotherapy with biphasic currents.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

SF-36 questionnaire

The SF-36 is a 36-question survey that assesses health-related quality of life, measuring eight key domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. It's a widely used tool in clinical practice and research for evaluating health status and assessing the impact of interventions.

Time frame: Before treatment, immediately after the treatment is finished and at two months later (follow-up)

Secondary Outcomes

Pittsburgh questionnaire

Sleep quality using the Pittsburgh questionnaire, consisting of 19 items that analyse 7 different components of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction). Each item is scored from 0 to 3. The total score of the scale ranges from 0 to 21 points where the lower end represents good sleep quality, and the upper end represents poor sleep quality

Time frame: Sleep quality was assessed before, immediately after and at two months

ICIQ-UI Short Form

Perception of frequency, severity of urinary incontinence (UI) and patient quality of life were assessed using the International Consultation on Incontinence Questionnaire (ICIQ-SF) validated questionnaire, where the individual's daily experience of urination and incontinence is answered with three scored items and one unmarked self-diagnostic item.

Time frame: ICIQ-SF was assessed before treatment, immediately after the treatment is finished and at two months later (follow-up)

Bladder Control Self-Assessment Questionnaire (B-SAQ)

Bladder symptoms and discomfort were assessed using the Bladder Control Self-Assessment Questionnaire (B-SAQ), a validated questionnaire consisting of 8 questions grouped into two scales, each with a scale of 0 to 3 points, giving a maximum score of 24 points (12 in each group).

Time frame: Before treatment, immediately after the treatment is finished and at two months later (follow-up)

Personal satisfaction of patients

After two months they were asked about their satisfaction with the treatment received (numerical scale from 0 not satisfied -10 very satisfied), whether they continued to do the exercises and whether they had any side effects after the treatment.

Time frame: In the follow-up (two month later)