Stress Urinary IncontinenceNCT06638489
Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence
A study testing High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) and Pelvic-Floor-Muscle-Training (PFMT) in people with Stress Urinary Incontinence, run by Hong Kong Metropolitan University at 1 site in China.
Trial summary
This study aimed to evaluate the impact of High-Intensity Focused Electromagnetic Therapy (HIFEM) combined with Pelvic Floor Muscle Training (PFMT) versus PFMT alone on urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) and Pelvic-Floor-Muscle-Training (PFMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 15 May 2024
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primipara or Multipara women aged 30 years or older with symptoms of stress urinary incontinence;
Who cannot join
- Those who had any contraindication for High-Intensity-Focused-Electromagnetic-Therapy (HIFEM);
- prior surgery for incontinence;
- taking drugs for bladder dysfunction or diuretics;
- hormone therapy;
- urgent or mixed urinary incontinence;
- incontinence associated with a neurologic condition;
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- inability to perform voluntary pelvic floor muscle contractions;
- cognitive impairment or dementia, major neurological disorders (such as stroke, cerebral palsy, multiple sclerosis);
- inability to carry out the treatment or evaluation;
- uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence: A Pilot for Randomised Controlled Trial
This study aimed to evaluate the impact of High-Intensity Focused Electromagnetic Therapy (HIFEM) combined with Pelvic Floor Muscle Training (PFMT) versus PFMT alone on urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence. Women aged 30 years or older exhibiting symptoms of stress urinary incontinence were randomized into two treatment groups. The experimental group received both HIFEM and PFMT, while the control group received only PFMT. The treatment continued for 6 weeks. Evaluations measured at baseline and post-intervention included the 1-hour Pad Test, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), and sonography to assess bladder neck movement.
- Conditions
- Stress Urinary Incontinence
- Being tested
- High-Intensity-Focused-Electromagnetic-Therapy (HIFEM), Pelvic-Floor-Muscle-Training (PFMT)
- 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-Therapy (HIFEM)Other
The HIFEM stimulation was administered using an Emsella instrument (manufactured by BTL Industry Inc., Boston, MA). The frequency ranged between 50 and 60Hz, and the intensity was as high as the patient could tolerate, which was usually up to 100%.
Pelvic-Floor-Muscle-Training (PFMT)Other
The PFMT protocol was that outlined by previous study. The participants were instructed to execute 5 rapid contractions over a span of 3 seconds and 10 prolonged contractions, each lasting between 3 to 8 seconds, with intervals of 10 seconds for relaxation in between, all while in a crook-lying position.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group received both High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) combined with Pelvic-Floor-Muscle-Training (PFMT) Receives: Other: High-Intensity-Focused-Electromagnetic-Therapy (HIFEM); Other: Pelvic-Floor-Muscle-Training (PFMT) |
| control group | Experimental | the control group received only Pelvic-Floor-Muscle-Training (PFMT) Receives: Other: Pelvic-Floor-Muscle-Training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-hour pad test
It measures the total amount of urine leakage by weighing the pad after performing several standardized activities over the course of an hour.
Measured: Baseline and the end of the 6-week intervention
Secondary outcomes (2)
International Consultation on Urinary Incontinence questionnaire (ICIQ-UI-SF)
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) is a widely used tool designed to assess the severity and impact of urinary incontinence on an individual's quality of life. The scores from these items provide an overall score that ranges from 0 to 20, with higher scores indicating greater severity of urinary incontinence and a more significant impact on quality of life.
Measured: Baseline and the end of the 6-week intervention
Bladder neck movement
The bladder neck movement was measured by sonography. The ultrasound scanner was a Clarius C3 HD3 (Clarius Mobile Health, Vancouver, Canada).
Measured: Baseline and the end of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Jun 2023
- Primary completion1 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIU FANG, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638489
- Sponsor's protocol ID
- N&HS00004
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan WS, Chow WT, Poon YT, Tsang CSL, Yuen HHL, Lui EWY, Wong YT, Tsang WWN. Effects of High-Intensity Focused Electromagnetic Therapy (HIFEM) With Pelvic Floor Muscle Training in Mothers Living With Incontinence: A Pilot for a Randomized Controlled Trial. Womens Health Issues. 2026 Mar-Apr;36(2):173-180. doi: 10.1016/j.whi.2025.12.002. Epub 2026 Jan 24.
PubMed 41582071
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence: A Pilot for Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06638489
- Acronym / sponsor ID
- N&HS00004
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 15 Oct 2024 (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 evaluate the impact of High-Intensity Focused Electromagnetic Therapy (HIFEM) combined with Pelvic Floor Muscle Training (PFMT) versus PFMT alone on urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence. Women aged 30 years or older exhibiting symptoms of stress urinary incontinence were randomized into two treatment groups. The experimental group received both HIFEM and PFMT, while the control group received only PFMT. The treatment continued for 6 weeks. Evaluations measured at baseline and post-intervention included the 1-hour Pad Test, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), and sonography to assess bladder neck movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: High-Intensity-Focused-Electromagnetic-Therapy (HIFEM), Other: Pelvic-Floor-Muscle-Training (PFMT)The experimental group received both High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) combined with Pelvic-Floor-Muscle-Training (PFMT) |
| control group | Experimental | Other: Pelvic-Floor-Muscle-Training (PFMT)the control group received only Pelvic-Floor-Muscle-Training (PFMT) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primipara or Multipara women aged 30 years or older with symptoms of stress urinary incontinence;
Key exclusion criteria (10 listed)
- Those who had any contraindication for High-Intensity-Focused-Electromagnetic-Therapy (HIFEM);
- prior surgery for incontinence;
- taking drugs for bladder dysfunction or diuretics;
- hormone therapy;
- urgent or mixed urinary incontinence;
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-Therapy (HIFEM)The HIFEM stimulation was administered using an Emsella instrument (manufactured by BTL Industry Inc., Boston, MA). The frequency ranged between 50 and 60Hz, and the intensity was as high as the patient could tolerate, which was usually up to 100%. | Other | experimental group |
| Pelvic-Floor-Muscle-Training (PFMT)The PFMT protocol was that outlined by previous study. The participants were instructed to execute 5 rapid contractions over a span of 3 seconds and 10 prolonged contractions, each lasting between 3 to 8 seconds, with intervals of 10 seconds for relaxation in between, all while in a crook-lying position. | Other | control group, experimental group |
Primary outcome
1-hour pad test
Time frame: Baseline and the end of the 6-week intervention
It measures the total amount of urine leakage by weighing the pad after performing several standardized activities over the course of an hour.
2 secondary outcomes
International Consultation on Urinary Incontinence questionnaire (ICIQ-UI-SF)
Time frame: Baseline and the end of the 6-week intervention
Bladder neck movement
Time frame: Baseline and the end of the 6-week 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 15 Oct 2024.
- Derived from this study: PubMed 41582071Chan WS, Chow WT, Poon YT, Tsang CSL, Yuen HHL, Lui EWY, Wong YT, Tsang WWN. Effects of High-Intensity Focused Electromagnetic Therapy (HIFEM) With Pelvic Floor Muscle Training in Mothers Living With Incontinence: A Pilot for a Randomized Controlled Trial. Womens Health Issues. 2026 Mar-Apr;36(2):173-180. doi: 10.1016/j.whi.2025.12.002. Epub 2026 Jan 24.
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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 High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) and Pelvic-Floor-Muscle-Training (PFMT) in people with Stress Urinary Incontinence, run by Hong Kong Metropolitan University at 1 site in China.
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 1 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 15 Oct 2024. 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 China. 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?
1-hour pad test (time frame: Baseline and the end of the 6-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638489, which also lists 1 linked publication.
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 15 Oct 2024.