Stress Urinary Incontinence
Conditions
Brief 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. 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.
Interventions
OTHERHigh-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%.
OTHERPelvic-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.
Sponsors
Hong Kong Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Primipara or Multipara women aged 30 years or older with symptoms of stress urinary incontinence;
Exclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-hour pad test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Urinary Incontinence questionnaire (ICIQ-UI-SF) | Baseline and the end of the 6-week intervention | 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. |
| Bladder neck movement | Baseline and the end of the 6-week intervention | The bladder neck movement was measured by sonography. The ultrasound scanner was a Clarius C3 HD3 (Clarius Mobile Health, Vancouver, Canada). |
Countries
China
Outcome results
None listed