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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

H

Hong Kong Metropolitan University

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Other: Pelvic-Floor-Muscle-Training (PFMT)
Other: High-Intensity-Focused-Electromagnetic-Therapy (HIFEM)

Study type

Interventional

Funder types

Other

Identifiers

NCT06638489
N&HS00004

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

experimental group
Experimental group
Description:
The experimental group received both High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) combined with Pelvic-Floor-Muscle-Training (PFMT)
Treatment:
Other: High-Intensity-Focused-Electromagnetic-Therapy (HIFEM)
Other: Pelvic-Floor-Muscle-Training (PFMT)
control group
Experimental group
Description:
the control group received only Pelvic-Floor-Muscle-Training (PFMT)
Treatment:
Other: Pelvic-Floor-Muscle-Training (PFMT)

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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