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

NCT ID: NCT06638489

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-05-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

experimental group

The experimental group received both High-Intensity-Focused-Electromagnetic-Therapy (HIFEM) combined with Pelvic-Floor-Muscle-Training (PFMT)

Group Type: EXPERIMENTAL

High-Intensity-Focused-Electromagnetic-Therapy (HIFEM)

Intervention Type: 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)

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Pelvic-Floor-Muscle-Training (PFMT)

Intervention Type: 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.

Interventions

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%.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hong Kong Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

LIU FANG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hong Kong Metropolitan University

Hong Kong, Hong Kong, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

N&HS00004

Identifier Type: -

Identifier Source: org_study_id