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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT06638489
• Lead Sponsor: Hong Kong Metropolitan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-15
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hong Kong Metropolitan University; 🇨🇳 Hong Kong, Hong Kong, China