Bladder Dysfunction
Conditions
Keywords
overactive bladder, Transcutaneous neuromodulation, Nesa Non-Invasive Neuromodulation, Posterior tibial nerve stimulation
Brief summary
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.
Interventions
DEVICENon-invasive neuromodulation NESA(NNG)
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.
DEVICENon-invasive Neuromodulation Posterior Tibial (NTPG)
NTPG is an electrotherapy using a device called NEUROTRAC MYOPLUS PRO (brand name) to perform non-invasive TENS-type electrotherapy with biphasic currents.
Sponsors
Daniel David Álamo Arce
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A single-blind, randomised controlled trial was conducted.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 questionnaire | Before treatment, immediately after the treatment is finished and at two months later (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh questionnaire | Sleep quality was assessed before, immediately after and at two months | 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 |
| ICIQ-UI Short Form | ICIQ-SF was assessed before treatment, immediately after the treatment is finished and at two months later (follow-up) | 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. |
| Bladder Control Self-Assessment Questionnaire (B-SAQ) | Before treatment, immediately after the treatment is finished and at two months later (follow-up) | 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). |
| Personal satisfaction of patients | In the follow-up (two month later) | 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. |
Countries
Spain
Contacts
Primary ContactRaquel I Medina-Ramírez, PhD. Physiotherapist
Backup ContactLaura FUENTES-APARICIO, PhD. Physical Therapy
Outcome results
None listed