High Intensity Magnetic Stimulation, Postmenopausal Women, Urge Urinary Incontinence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTPelvic floor muscle training + Pelvic magnetic stimulation
Postmenopausal women received pelvic floor muscle training (PFMT) combined with pelvic magnetic stimulation (PMS).
DIAGNOSTIC_TESTPelvic floor muscle training
Postmenopausal women received pelvic floor muscle training (PFMT) through Kegel exercises.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urogenital distress inventory questionnaire (UDI-6) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Impact Questionnaire (IIQ-7) | Six-week post-intervention | The Incontinence Impact Questionnaire (IIQ-7) was used to evaluate the impact of urinary incontinence on health-related quality of life in women and to determine the extent to which urinary symptoms interfere with daily activities. Questionnaire description The IIQ-7 consists of seven items covering four domains: * Physical activity * Travel * Social/relationships * Emotional health Scoring Each item is scored on a four-point Likert scale: * 0 = Not at all * 1 = Slightly * 2 = Moderately * 3 = Greatly The mean score of completed items is multiplied by 33.3, producing a total score ranging from 0 to 100. |
| International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | Six-week post-intervention | The International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) was used to comprehensively evaluate female lower urinary tract symptoms and their impact on quality of life. Questionnaire description The questionnaire evaluates urinary filling symptoms, voiding symptoms, incontinence symptoms, and associated quality-of-life impairment. Scoring Items are scored according to the official ICIQ-FLUTS scoring system, with higher scores reflecting greater symptom severity and quality-of-life impairment |
Countries
Egypt
Outcome results
None listed