Effect of High Intensity Magnetic Stimulation on Urge Urinary Incontinence in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Urogenital distress inventory questionnaire (UDI-6)
研究概览
简要总结
This study aimed to assess the efficacy of high-intensity magnetic stimulation (HIMS) as a non-invasive, safer, and more patient-friendly treatment alternative for urge urinary incontinence (UUI) in postmenopausal women.
详细描述
Urinary incontinence (UI) is a widespread health issue affecting more than 50% of postmenopausal women, significantly impacting their quality of life.
Urge Urinary Incontinence (UUI) is characterized by a sudden, intense urge to urinate that is difficult to postpone, often leading to involuntary leakage. While UUI can occur without a clear neurological cause in otherwise healthy women, it is also common in those with neurological disorders such as Parkinson's disease, multiple sclerosis, or spinal nerve injuries.
Magnetic Stimulation (MS) has emerged as a promising, non-invasive approach for managing UUI. Introduced in 1998, MS uses Faraday's law of magnetic induction to generate electrical currents that depolarize nerves and stimulate pelvic floor muscles, promoting muscle strength and endurance over time.
Considering the significant occurrence of UUI in postmenopausal women and the limitations of existing conservative and surgical approaches, this proposal seeks to assess the efficacy of High-Intensity Magnetic Stimulation (HIMS) as a non-invasive treatment alternative to enhance bladder control and pelvic floor muscle strength in this group.
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
- None
入排标准
- 年龄范围
- 50 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: Between 50 and 55 years, as urinary control disorders such as urgency Urinary Incontinence (UUI) are more prevalent in this age group.
- •Diagnosis: Presence of UUI only, without overlap with other types of urinary incontinence.
- •Body Mass Index (BMI): Normal range (18.5-25) to minimize the effect of obesity on pelvic muscle strength and treatment outcomes.
- •Delivery History: 2-4 vaginal deliveries, since the number of deliveries can affect pelvic floor muscle function.
- •Informed Consent: Willingness to sign a consent form and participate in the study.
排除标准
- •Other Types of Urinary Incontinence: Mixed urinary incontinence (MUI) or stress urinary incontinence (SUI), to avoid confounding outcomes.
- •Overweight/Obesity: BMI > 25, as excess weight may affect pelvic floor muscle function and treatment response.
- •Cesarean Deliveries: To avoid anatomical differences in pelvic support compared to vaginal deliveries.
- •Chronic Diseases: Diabetes mellitus (DM) or hypertension (HTN), which may influence bladder function or muscle strength.
- •Number of Deliveries: Fewer than 2 or more than 4 deliveries, to minimize variability in pelvic floor condition.
- •Pelvic Organ Prolapse: Could affect assessment of pelvic floor muscle function and bladder performance.
- •Neurological Conditions: Parkinson's disease, multiple sclerosis, spinal cord injuries, or loss of sensation in the pelvic region or lower limbs, as these affect muscular and sensory control.
- •Infections or Inflammation: Urinary tract infections, bladder inflammation, or active pelvic infections, to ensure safe application of magnetic stimulation.
- •History of Malignancy or Cardiac Arrhythmias: To reduce health risks during intervention.
- •Presence of metallic implants or implanted electronic devices (e.g., cardiac pacemakers, implantable cardioverter-defibrillators, neurostimulators, or cochlear implants).
结局指标
主要结局
Urogenital distress inventory questionnaire (UDI-6)
时间窗: Six-week post-intervention
The urogenital distress inventory questionnaire (UDI-6) was used to assess the severity of lower urinary tract symptoms and the degree of symptom-related distress experienced by women with urge urinary incontinence. Questionnaire description The UDI-6 contains six items evaluating: * Urinary frequency * Urgency urinary leakage * Stress urinary leakage * Leakage during coughing or sneezing * Difficulty emptying the bladder * Lower abdominal or genital discomfort Scoring Responses are averaged and multiplied by 25, producing a total score ranging from 0 to 100
次要结局
- Incontinence Impact Questionnaire (IIQ-7)(Six-week post-intervention)
- International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)(Six-week post-intervention)
研究者
Marwa Awad Awad Alsuhaimi
B.Sc. in Physical Therapy, Kafrelsheikh University, Kafrelsheikh, Egypt.
Kafrelsheikh University