Urinary Incontinence, Stress IncontinenceNCT05693103
The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms
An observational study of Urinary Incontinence, Stress Incontinence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is aimed at women's pelvic floor muscles, especially urinary incontinence caused by pelvic floor muscle relaxation or pelvic prolapse, to observe whether the use of (HIFEM) high-intensity focused magnetic energy chairs can help the pelvic floor muscles after this treatment Strengthening to improve the… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress Incontinence
- What is being tested?
- High-Intensity Focused Electromagnetic therapy
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2021to 30 Jun 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 20 years and older
- Women only
- Adult, Older adult
Study population: Collect 30 women with urinary incontinence symptoms (including: stress urinary incontinence, urge urinary incontinence)
Who may be able to join
- Women over 20 years old.
- Symptoms of urinary incontinence (including: stress incontinence, urge incontinence).
- Blood tests confirmed that the number of platelets was 150,000-450,000/UL, and the coagulation function (PT) index was normal.
Who cannot join
- Pregnant and lactating women.
- Patients with acute or chronic cardiovascular disease.
- Patients with acute or chronic infectious diseases.
- Patients with malignant tumors, uterine fibroids, and gynecological cysts, who have been evaluated by doctors as unsuitable.
- Those who have undergone lower abdominal or genital-related surgery and have been evaluated by doctors as unsuitable.
- Patients with pulmonary insufficiency.
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- People with metal and electronic implants (such as: pacemaker, defibrillator, neurostimulator).
- Those with bleeding disorders or receiving anticoagulant therapy.
- Use drug pumps.
- People with skin allergies or skin diseases.
- Those unable to sign the subject's consent form.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Cheng-Yu Long, PhD, +886-7-3121101 ext. 6428, urolong@yahoo.com.tw
About this study
This study is aimed at women's pelvic floor muscles, especially urinary incontinence caused by pelvic floor muscle relaxation or pelvic prolapse, to observe whether the use of (HIFEM) high-intensity focused magnetic energy chairs can help the pelvic floor muscles after this treatment Strengthening to improve the symptoms of urinary incontinence caused by the compression of the sacral nerve plexus caused by the downward movement of the uterus, thereby improving the social life and quality of life of the patient.
- Being tested
- High-Intensity Focused Electromagnetic therapy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Focused Electromagnetic therapyDevice
Also called EMSELLA
The HPM-6000UF is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body.
The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Incontinence | Stress Urinary Incontinence Urge incontinence Receives: Device: High-Intensity Focused Electromagnetic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic study
Urodynamic testing is any procedure that looks at how well parts of the lower urinary tract-the bladder, sphincters, and urethra-work to store and release urine. Most urodynamic tests focus on how well your bladder can hold and empty urine. Urodynamic tests can also show whether your bladder is contracting when it's not supposed to, causing urine to leak.
Measured: One hour
Questionnaire
Female Sexual Function Index, International Consultation on Incontinence Questionnaire, Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, The International Consultation on Incontinence, Pelvic Organ Prolapse Distress Inventory-6, Overactive Bladder Symptom Score, The global response assessment.
Measured: fifteen minutes
Physiological parameter
Age, BMI in kg/m^2, Pregnancy and childbirth, Year of Symptoms
Measured: five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start15 Aug 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693103
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210133
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms
- ClinicalTrials.gov ID
- NCT05693103
- Acronym / sponsor ID
- KMUHIRB-F(I)-20210133
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Jan 2023 (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 is aimed at women's pelvic floor muscles, especially urinary incontinence caused by pelvic floor muscle relaxation or pelvic prolapse, to observe whether the use of (HIFEM) high-intensity focused magnetic energy chairs can help the pelvic floor muscles after this treatment Strengthening to improve the symptoms of urinary incontinence caused by the compression of the sacral nerve plexus caused by the downward movement of the uterus, thereby improving the social life and quality of life of the patient.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urinary Incontinence | – | Device: High-Intensity Focused Electromagnetic therapyStress Urinary Incontinence Urge incontinence |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Collect 30 women with urinary incontinence symptoms (including: stress urinary incontinence, urge urinary incontinence)
Key inclusion criteria (3 listed)
- Women over 20 years old.
- Symptoms of urinary incontinence (including: stress incontinence, urge incontinence).
- Blood tests confirmed that the number of platelets was 150,000-450,000/UL, and the coagulation function (PT) index was normal.
Key exclusion criteria (11 listed)
- Pregnant and lactating women.
- Patients with acute or chronic cardiovascular disease.
- Patients with acute or chronic infectious diseases.
- Patients with malignant tumors, uterine fibroids, and gynecological cysts, who have been evaluated by doctors as unsuitable.
- Those who have undergone lower abdominal or genital-related surgery and have been evaluated by doctors as unsuitable.
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 |
|---|---|---|
| High-Intensity Focused Electromagnetic therapyAlso: EMSELLAThe HPM-6000UF is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation. | Device | Urinary Incontinence |
Primary outcome
Urodynamic study
Time frame: One hour
Urodynamic testing is any procedure that looks at how well parts of the lower urinary tract-the bladder, sphincters, and urethra-work to store and release urine. Most urodynamic tests focus on how well your bladder can hold and empty urine. Urodynamic tests can also show whether your bladder is contracting when it's not supposed to, causing urine to leak.
Questionnaire
Time frame: fifteen minutes
Female Sexual Function Index, International Consultation on Incontinence Questionnaire, Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, The International Consultation on Incontinence, Pelvic Organ Prolapse Distress Inventory-6, Overactive Bladder Symptom Score, The global response assessment.
Physiological parameter
Time frame: five minutes
Age, BMI in kg/m^2, Pregnancy and childbirth, Year of Symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Stress Incontinence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Yu Long, PhD (+ 886 7 3121101 ext. 6428, urolong@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urodynamic study (time frame: One hour). The study lists 3 primary outcomes in all. 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 20 Jan 2023.