Non-invasive NESA Neuromodulation Versus Transcutaneous Posterior Tibial Nerve Stimulation for the Treatment of Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- SF-36 questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
SF-36 questionnaire
时间窗: 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.
次要结局
- Pittsburgh questionnaire(Sleep quality was assessed before, immediately after and at two months)
- ICIQ-UI Short Form(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)(Before treatment, immediately after the treatment is finished and at two months later (follow-up))
- Personal satisfaction of patients(In the follow-up (two month later))
研究者
Daniel David Álamo Arce
Proffesor
University of Las Palmas de Gran Canaria