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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: High-Intensity-Focused-Electromagnetic-Therapy (HIFEM); Other: Pelvic-Floor-Muscle-Training (PFMT)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China, 999077
      • Hong Kong Metropolitan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The experimental group received both High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) combined with Pelvic-Floor-Muscle-Training (PFMT)	Other: 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: 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.
Experimental: control group; the control group received only Pelvic-Floor-Muscle-Training (PFMT)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Hong Kong Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: N&HS00004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No