Effect of a Peripheral and Central Neuromodulation Protocol Combined With the Application of Therapeutic Exercise in Patients Diagnosed With Urinary Incontinence. A Randomized Control Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- The Overactive Bladder Questionnaire-Short Form
研究概览
简要总结
Urge urinary incontinence (UUI) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder affecting healthcare systems worldwide. The efficacy of therapeutic exercise and neuromodulation in the treatment of UUI is evaluated, and these techniques are combined.
详细描述
Urge urinary incontinence (UUI) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder that affects the neurophysiology of micturition and bladder functionality, particularly in processes associated with menopause, leading to a deterioration in quality of life. Various therapeutic approaches are employed to treat overactive bladder. Among the most frequently implemented interventions are sacral or tibial nerve neurostimulation. This intervention targets the pathophysiological substrate by modulating the somatic afferent activity of the bladder and interfering with the activity of fibers responsible for pain modulation and neuromuscular system functionality. In essence, the described approach focuses on reducing peripheral input. Based on the aforementioned information, it was hypothesized that training through a pelvic floor strength protocol, performed adjunctively with peripheral neuromodulation prior to its implementation, may provide the ability to inhibit detrusor contractions via involuntary contractions of the perineal musculature.
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
- Double (Participant, Investigator)
盲法说明
The groups will be arranged randomly, and the masking technique to be employed will be a double-blind procedure. The subjects will be randomly selected utilizing the EPIDAT 3.1 program. Both the participants and the investigator responsible for data collection remained unaware of the assigned intervention and the results obtained, respectively, until the study's conclusion. An independent researcher, employing an Excel formula, generated a table of random numbers to blind data collectors and outcome adjudicators, thereby ensuring unbiased outcome ascertainment.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Present with a diagnosis of urinary incontinence or overactive bladder
- •Women of menopausal age (>45 years)
- •≥3 months of duration
- •Fulfill the established criteria for patient selection for neuromodulation treatment (urge urinary incontinence)
- •Speak native Spanish or English
排除标准
- •Prior or scheduled surgical procedures in the lumbar or abdominal region
- •Presence of fractures or severe pathological conditions
- •Current pregnancy or potential for pregnancy during the study period
- •Neurological or psychiatric disorders
- •Presence of stress urinary incontinence
- •Female subjects with autoimmune diseases or malignancies
- •Belonephobia
- •Subjects who have undergone previous neuromodulation
研究组 & 干预措施
Exercise + neuromodulation
The Intervention group will initially undergo posterior tibial nerve neuromodulation following a standardized protocol: 30 minutes per session, 2 sessions per week for 3 months. Sessions will have a duration of 60 minutes and will be structured into three distinct blocks. In the initial two treatment blocks, exercises will emphasize CORE stabilization and general strength training with forced exhalation to ensure appropriate activation of the transverse abdominal muscle, with the objective of preventing adverse effects associated with increased intra-abdominal pressure. The third work block will focus on addressing anticipatory postural adjustment control, given its established relationship with the pelvic floor muscles. This technique will be actively implemented in conjunction with the Proprioceptive Postural Reeducation Method (5P® LOGSURF).
干预措施: Neuromodulation (Procedure)
Exercise + neuromodulation
The Intervention group will initially undergo posterior tibial nerve neuromodulation following a standardized protocol: 30 minutes per session, 2 sessions per week for 3 months. Sessions will have a duration of 60 minutes and will be structured into three distinct blocks. In the initial two treatment blocks, exercises will emphasize CORE stabilization and general strength training with forced exhalation to ensure appropriate activation of the transverse abdominal muscle, with the objective of preventing adverse effects associated with increased intra-abdominal pressure. The third work block will focus on addressing anticipatory postural adjustment control, given its established relationship with the pelvic floor muscles. This technique will be actively implemented in conjunction with the Proprioceptive Postural Reeducation Method (5P® LOGSURF).
干预措施: Exercise (Procedure)
Exercise+ ShamNeuromodulation
For the SHAM group, a non-penetrating needle with a retractable handle will be utilized, which is commonly employed in experimental research with Streitberger and Kleinhenz placebo needles. This method creates the appearance of insertion without penetrating the skin and allows the needles to remain in situ for the duration of the intervention. The SHAM group participants will adhere to the exercise protocol in the same manner as the intervention group.
干预措施: Exercise (Procedure)
Exercise+ ShamNeuromodulation
For the SHAM group, a non-penetrating needle with a retractable handle will be utilized, which is commonly employed in experimental research with Streitberger and Kleinhenz placebo needles. This method creates the appearance of insertion without penetrating the skin and allows the needles to remain in situ for the duration of the intervention. The SHAM group participants will adhere to the exercise protocol in the same manner as the intervention group.
干预措施: Sham Neuromodulation (Procedure)
Control Group
Conventional Physiotherapy. The control group engages in specific pelvic floor exercises, which are less complex in terms of neuromuscular processing (focusing on fundamental spinal stimuli), in contrast to the more comprehensive and intricate tasks of the intervention group. Additionally, manual therapy techniques are employed to inhibit trigger points in the musculature and ligamentous structures of the pelvic cavity, as well as intracavitary techniques aimed at alleviating mechanical pain.
干预措施: Exercise control group (Procedure)
结局指标
主要结局
The Overactive Bladder Questionnaire-Short Form
时间窗: At baseline, Post1month, Post3months, Post6months
The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a concise, self-administered patient-reported outcomes instrument comprising two scales that assess symptom bother and health-related quality of life (HR-QOL) in patients with OAB. This self-administered, disease-specific questionnaire evaluates symptomatic discomfort (6 items) and health-related quality of life (HRQoL, 13 items) using a 6-point Likert scale. Scores are transformed to a 0-100 scale, where higher symptom scores indicate greater severity, and higher HRQoL scores reflect better quality of life
次要结局
- Mapping of Incontinence Quality of Life (I-QOL)(at baseline, Post1month, Post3months, Post6months)
- Bladder Diary(at baseline, Post1month, Post3months, Post6months)
- Urinary Incontinence Short Form (ICIQ-UI-SF)(at baseline, Post1month, Post3months, Post6months)
- Electromyography (EMG)(at baseline, Post1month, Post3months, Post6months)
- Oxford Scale(at baseline, Post1month, Post3months, Post6months)
- Tampa Scale-11 (TSK-11)(at baseline, Post1month, Post3months, Post6months)
- Pain Catastrophizing Scale (PCS)(at baseline, Post1month, Post3months, Post6months)
- Sport Injury Rehabilitation Adherence Scales (SIRAS)(at baseline, Post1month, Post3months, Post6months)