High Intensity Magnetic StimulationNCT07731711
High Intensity Magnetic Stimulation on Urge Urinary Incontinence in Postmenopausal Women
A study testing Pelvic floor muscle training + Pelvic magnetic stimulation and Pelvic floor muscle training in people with High Intensity Magnetic Stimulation and Urge Urinary Incontinence, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 55 years, women only
- Conditions the study is for
- High Intensity Magnetic Stimulation, Urge Urinary Incontinence, Postmenopausal Women
- What is being tested?
- Pelvic floor muscle training + Pelvic magnetic stimulation and Pelvic floor muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2025to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University (Faculty of Physical Therapy)
Kafr ash Shaykh, Kafrelsheikh, 33516
About this study
Official title: Effect of 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.
Read the 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.
- Being tested
- Pelvic floor muscle training + Pelvic magnetic stimulation, Pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training + Pelvic magnetic stimulationDiagnostic test
Postmenopausal women received pelvic floor muscle training (PFMT) combined with pelvic magnetic stimulation (PMS).
Pelvic floor muscle trainingDiagnostic test
Postmenopausal women received pelvic floor muscle training (PFMT) through Kegel exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) (Study group) | Experimental | Postmenopausal women received pelvic floor muscle training (PFMT) combined with pelvic magnetic stimulation (PMS). Receives: Diagnostic Test: Pelvic floor muscle training + Pelvic magnetic stimulation |
| Group (B) (Control group) | Active comparator | Postmenopausal women received pelvic floor muscle training (PFMT) through Kegel exercises. Receives: Diagnostic Test: Pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urogenital distress inventory questionnaire (UDI-6)
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
Measured: Six-week post-intervention
Secondary outcomes (2)
Incontinence Impact Questionnaire (IIQ-7)
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.
Measured: Six-week post-intervention
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
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
Measured: Six-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start21 Sep 2025
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Awad Awad Alsuhaimi, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731711
- Sponsor's protocol ID
- KFSIRB200-670
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Magnetic Stimulation on Urge Urinary Incontinence in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07731711
- Acronym / sponsor ID
- KFSIRB200-670
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 21 Sep 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) (Study group) | Experimental | Diagnostic Test: Pelvic floor muscle training + Pelvic magnetic stimulationPostmenopausal women received pelvic floor muscle training (PFMT) combined with pelvic magnetic stimulation (PMS). |
| Group (B) (Control group) | Active comparator | Diagnostic Test: Pelvic floor muscle trainingPostmenopausal women received pelvic floor muscle training (PFMT) through Kegel exercises. |
Who may qualify
- Ages
- 50 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training + Pelvic magnetic stimulationPostmenopausal women received pelvic floor muscle training (PFMT) combined with pelvic magnetic stimulation (PMS). | Diagnostic test | Group (A) (Study group) |
| Pelvic floor muscle trainingPostmenopausal women received pelvic floor muscle training (PFMT) through Kegel exercises. | Diagnostic test | Group (B) (Control group) |
Primary outcome
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
2 secondary outcomes
Incontinence Impact Questionnaire (IIQ-7)
Time frame: Six-week post-intervention
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time frame: Six-week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training + Pelvic magnetic stimulation and Pelvic floor muscle training in people with High Intensity Magnetic Stimulation and Urge Urinary Incontinence, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urogenital distress inventory questionnaire (UDI-6) (time frame: Six-week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.