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

NCT06638489 | Completed

• 1 other identifier: N&HS00004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

experimental group

EXPERIMENTAL

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); Other: Pelvic-Floor-Muscle-Training (PFMT)

control group

EXPERIMENTAL

the control group received only Pelvic-Floor-Muscle-Training (PFMT)

Other: Pelvic-Floor-Muscle-Training (PFMT)

Interventions

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%.

experimental group

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.

control group; experimental group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primipara or Multipara women aged 30 years or older with symptoms of stress urinary incontinence;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong, 999077, China

Location

Related Publications (1)

• Chan WS, Chow WT, Poon YT, Tsang CSL, Yuen HHL, Lui EWY, Wong YT, Tsang WWN. Effects of High-Intensity Focused Electromagnetic Therapy (HIFEM) With Pelvic Floor Muscle Training in Mothers Living With Incontinence: A Pilot for a Randomized Controlled Trial. Womens Health Issues. 2026 Jan 24:S1049-3867(25)00160-4. doi: 10.1016/j.whi.2025.12.002. Online ahead of print.

  PMID: 41582071 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: June 15, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 15, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)