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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | The experimental group received both High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) combined with Pelvic-Floor-Muscle-Training (PFMT) |
|
| control group | Experimental | the control group received only Pelvic-Floor-Muscle-Training (PFMT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and the end of the 6-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Metropolitan University | Hong Kong | Hong Kong | 999077 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41582071 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2024 |
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|
| 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. |
|
| 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). | Baseline and the end of the 6-week intervention |
| Oct 9, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2023 | Oct 9, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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