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Completed

NCT Number: NCT07731711

High Intensity Magnetic Stimulation on Urge Urinary Incontinence in Postmenopausal Women

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pelvic floor muscle training + Pelvic magnetic stimulation

Diagnostic Test

Postmenopausal women received pelvic floor muscle training (PFMT) combined with pelvic magnetic stimulation (PMS).

Pelvic floor muscle training

Diagnostic Test

Postmenopausal women received pelvic floor muscle training (PFMT) through Kegel exercises.

Primary outcomes

  1. Urogenital distress inventory questionnaire (UDI-6)

    Time frame: 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 outcomes

  1. Incontinence Impact Questionnaire (IIQ-7)

    Time frame: 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.
  2. International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Effect of High Intensity Magnetic Stimulation on Urge Urinary Incontinence in Postmenopausal Women

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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