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Clinical Trials/NCT06638489
NCT06638489
Completed
Not Applicable

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

Hong Kong Metropolitan University1 site in 1 country40 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Hong Kong Metropolitan University
Enrollment
40
Locations
1
Primary Endpoint
1-hour pad test
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
May 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LIU FANG

Principal Investigator

Hong Kong Metropolitan University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • International Consultation on Urinary Incontinence questionnaire (ICIQ-UI-SF)(Baseline and the end of the 6-week intervention)
  • Bladder neck movement(Baseline and the end of the 6-week intervention)

Study Sites (1)

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