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Completed

NCT Number: NCT06638489

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

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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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Metropolitan University

Hong Kong, 999077, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%.

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.

Primary outcomes

  1. 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

  1. International Consultation on Urinary Incontinence questionnaire (ICIQ-UI-SF)

    Time frame: 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.

  2. Bladder neck movement

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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