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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hong Kong Metropolitan University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-05-01
• Completion: 2024-05-15
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China