Corelife Wellness web logo - Pelvic Floor Fitness Experts

The Research · Full study · 2020

Randomized Multi-Center Trial of HIFEM Pelvic Floor Stimulation Device Compared with Pelvic Floor Exercises for Treatment of Urinary Incontinence: Evaluation of Initial Single-Center Data

Pelvic floor exercise is sometimes recommended for women experiencing urinary incontinence. Patients might benefit either from HIFEM or pelvic floor muscle training.

Conclusions

The HIFEM procedure tended to have a higher impact on subjects by the means of objective and subjective examination.

  • Reduced use of pads
  • More comfortable
  • Improved quality of life

Stephanie Molden, MD1

1The Female Pelvic Health Center, Newtown, PA, USA

Abstract accepted for oral presentation at ASLMS 2020

HIFEM® PROCEDURE AND PELVIC FLOOR EXERCISE FOR URINARY INCONTINENCE

HIGHLIGHTS

  • Initial short-term data demonstrated that patients might benefit either from HIFEM or pelvic floor muscle training (PFMT) procedures for urinary incontinence (UI).
  • Preliminary evaluation suggests higher level of improvement after HIFEM procedure.
  • HIFEM procedure resulted in considerable reduction of incontinence pads usage.
  • Subjects reported positive changes in their quality of life resulting from reduction of UI symptoms and regained control over the PFM muscles.
  • HIFEM procedure was found to be more comfortable.

DESIGN AND METHODOLOGY

  • Fifteen subjects with various UI symptoms were recruited and randomly divided into the HIFEM (N=8, 57.4±5.9 years) and PFMT (N=7, 51.9±12.7 years) groups.
  • All subjects completed six HIFEM treatments or PFMT sessions performed twice a week for three weeks.
  • The same evaluation methodology was used in both groups in regards to comparison of achieved results.
  • Subject’s evaluation included various methods: UDI-6, ICIQ-LUTSqol, 3-day ICIQ-BD, Pad Usage, maximal voluntary contraction measurement using biofeedback and digital palpation, therapy comfort and subject satisfaction questionnaire.
  • Safety of the HIFEM procedure and pelvic floor exercise was documented.
Table: Number of participants at the baseline, after 6th treatment (Tx) and follow-up visits.
GroupBaseline (N)After 6th (N)1-month FU (N)3-month FU (N)
HIFEM8665
PFMT7843

RESULTS

  • Assessment of pelvic floor contractions revealed muscle strength enhancement in both groups which led to improvement of subjects’ continence.
  • The HIFEM procedure tended to have a higher impact on subjects by the means of objective and subjective examination.
  • The 3-day bladder diary in HIFEM group revealed considerable decrease of pad usage by -1.2 pads/24 hours, reported at 3 months.
  • At 3-month follow-up, the average bladder sensation decreased by 38.9% (-0.82 points on 0-4 scale) after HIFEM procedure while PFMT group score returned to its baseline values.
  • UDI-6 and ICIQ-LUTSqol questionnaires in both groups indicated clinically significant improvement of subject’s quality of life after the treatment and at both completed followups.
  • Subjects found the HIFEM procedure to be more comfortable then exercise.
  • Both treatment modalities showed to be safe, as no adverse events were observed.
  • More data with longer follow-up is needed to corroborate the interim results.
Figure: ICIQ-LUTSqol and UDI-6 scores were continuously decreasing in both groups and exceeded minimally clinically important difference of 4 points…Figure: ICIQ-LUTSqol and UDI-6 scores were continuously decreasing in both groups and exceeded minimally clinically important difference of 4 points… (image 2)
Figure: ICIQ-LUTSqol and UDI-6 scores were continuously decreasing in both groups and exceeded minimally clinically important difference of 4 points or 11 points respectively.
Text version of this figure

Two bar charts comparing the HIFEM group (blue bars) with the PFMT group (red bars) at Baseline, 1 month and 3 months. The first chart shows the mean UDI-6 score (vertical axis from 0 to 60); the second shows the mean ICIQ-LUTSqol score (vertical axis from 0 to 45). In both charts the scores are lower at 1 month than at baseline, and lower again at 3 months.

About this page

This page reproduces the full text of a research paper so that it can be read, searched and shared on our website. The wording, numbers, tables, figures and references are as printed in the PDF, including any typing slips in the original. Running headers and footers, page numbers and line-break artefacts were left out. To make the page easier to navigate and to read with a screen reader, a few labels were added: section headings the PDF did not print (for example “Abstract”), names for tables the PDF left untitled, and a “Text version” under figures that contain words. The original PDF can be downloaded above.

  • Citation: Molden S. Randomized Multi-Center Trial of HIFEM Pelvic Floor Stimulation Device Compared with Pelvic Floor Exercises for Treatment of Urinary Incontinence: Evaluation of Initial Single-Center Data. Abstract accepted for oral presentation at ASLMS 2020.
  • Licence: Not stated in the PDF

Corelife Wellness did not conduct this study, and the words above are the authors’ own. The Libby Chair is our name for BTL Emsella, which uses the HIFEM technology studied in this paper. Browse all 13 studies, or contact the clinic or call 289-608-7136 with any questions.

This page is general information, not medical advice. A health professional can tell you whether this treatment is right for you.

About this study

What did this study conclude?

The HIFEM procedure tended to have a higher impact on subjects by the means of objective and subjective examination.

Who presented this study, and where can I read the original?

It was presented by Molden S at ASLMS 2020 (American Society for Laser Medicine and Surgery), abstract accepted for oral presentation. The full text is on this page, and the original PDF can be downloaded from it.

What is the Libby Chair?

The Libby Chair is our name for BTL Emsella, which uses a high-intensity focused electromagnetic field (HIFEM) to deliver thousands of supramaximal pelvic floor muscle contractions. It involves no needles, no penetration and no need to undress. Corelife Wellness offers it in Oakville, Ontario.

Corelife Wellness - Pelvic Floor and Core Health Fitness Experts

Powerful pelvic health care by professionals, for you.

Book Free Consultation