MedTrace Logo

Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial

NCT06485167 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-03

No results posted yet for this study

Summary

Urinary incontinence (UI) is a condition with involuntary leakage of urine. UI has a significant impact on health related quality of life, poorer sleep quality and sexual function, reduced participation in social and physical activities and is associated with large health care charge. Non-surgical method is always recommended as first action with a step-by-step care starting from non-invasive to more invasive interventions. Systematic overview shows that available non-surgical treatment options in primary care indicated low results in improving effect. HIFEM® technology is a non-invasive method and studies showed significant result on women with UI. For Swedish healthcare HIFEM® is a new medical technology product to treat UI. However, there is a lack of knowledge about the HIFEM® effect in women seeking primary care.

The aim is to evaluate the effect of high-intensity electromagnetic energy (HIFEM®) on pelvic floor muscles, urinary leakage, sexual function, and health-related quality of life in women with urinary leakage in Swedish primary care, as well as to evaluate cost-effectiveness.

The intervention included six 30 minutes HIFEM® sessions once a week over six weeks compared with control group.

The results are expected to lead to effective non-surgical treatment options that can reach many patients, contribute to improving existing routines and can be a new potential way to support health promotion care in primary care and be a cost-effective investment.

Conditions

Interventions

DEVICE

HIFEM- chair

The intervention consists of pelvic floor training combined with high-intensity electromagnetic energy treatment (HIFEM®). This includes six HIFEM® treatments (each lasting 28 minutes) with one session per week over six weeks. The woman completes a voiding diary before treatment and one week (±7 days) after treatment. She sits fully clothed on the HIFEM chair.

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Lena Rindner, PhD · Vastra Gotaland Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-12-01
Completion
2025-12-15

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485167 on ClinicalTrials.gov