A small randomised study reported sustained symptom-related quality-of-life improvements after HIFEM treatment, but its comparison with a specific exercise programme does not establish that EMSELLA replaces or universally outperforms supervised pelvic-floor care.
Where newer controlled research fits
Two newer controlled studies ask a related question about adding electromagnetic treatment to pelvic-floor exercises. A 40-participant pilot comparing active treatment plus exercises with sham treatment plus exercises did not establish a significant group-by-time interaction for its reported outcomes. A separate 44-participant study reported advantages on selected outcomes. These designs should be read alongside the 12-month trial, not combined into a universal claim that one treatment always outperforms exercises.
Sources: 40-participant pilot and 44-participant comparison.
Study at a glance
Design: Small randomised active-comparator study; newer related sham-controlled pilot considered separately.
Participants: Final published abstract: 38 women; earlier conference summary: 47; complete arm and follow-up counts not verified.
Research protocol: Six sessions; detailed PFMT supervision and adherence not verified from accessible abstract.
Follow-up: One, three, six, nine and twelve months described.
Evidence visual: The comparator and the clock both matter
Separate six-month point changes from twelve-month percentage changes.
Six months
HIFEM: 15.2 ICIQ-LUTSqol point reduction; Exercise comparator: 5.1 ICIQ-LUTSqol point reduction.
A positive reduction means improvement here. A significant within-group result and a non-significant result in another group do not establish a direct between-group difference.
Twelve months
HIFEM: 24 % ICIQ-LUTSqol improvement; Exercise comparator: -3 % ICIQ-LUTSqol improvement.
The negative improvement value means 3% worsening. These figures belong to twelve months, not three months.
Urgency at 12 months
HIFEM: 32 % urgency improvement; Exercise comparator: 5 % urgency improvement.
Final published abstract figures. Do not substitute the earlier conference figure of 34%.
Related 2026 pilot
A separate 40-woman pilot of active or sham HIFEM added to PFMT did not show a significant time-by-group interaction. This is not a plotted zero effect or the same study.
Source for the visual: [S12, S17, G02]. Small-study group results. Supervised pelvic-floor muscle training remains guideline-supported first-line care for women with stress or mixed urinary incontinence.
Two approaches to a shared clinical goal
Pelvic-floor muscle training and electromagnetic stimulation both appear in discussions about urinary incontinence, but they are not identical interventions. Exercise-based care can involve assessment, learning a correct contraction, coordination, progression and a home programme. A device course delivers stimulation according to a different protocol. A useful comparison must describe what each group actually received. [S12, G02]
The study by Guerette and colleagues followed women assigned to HIFEM treatment or a pelvic-floor muscle training programme. Its longer follow-up makes it relevant to questions about sustained symptom-related quality of life. It is one piece of evidence, not a verdict on every form of pelvic-floor rehabilitation.
For treatment background, read Are EMSCULPT NEO and EMSELLA safe?. This article focuses on the specific research question.
Which version of the study are we discussing?
The final published abstract in Journal of Women's Health Care reports 38 women aged 27 to 66 years. It describes six treatment sessions, with follow-up extending to 12 months. An earlier conference summary reported 47 women and slightly different headline results. This article uses the final published abstract rather than combining those versions. [S12]
The accessible abstract does not establish all arm-specific and visit-specific participant counts, nor the full details of exercise supervision, home practice and adherence. Those gaps matter when applying the result to a different exercise programme. We therefore do not assume a particular group allocation or equate the comparator with an optimally delivered course of specialist physiotherapy.
What did the researchers measure?
The principal questionnaire discussed here is ICIQ-LUTSqol, which measures the effect of lower urinary tract symptoms on quality of life. It is not the same questionnaire as the ICIQ-SF symptom score used in several other EMSELLA studies. The score values should not be pooled or compared as though they use the same scale. [S12]
The researchers also reported urgency, leakage and pad-related outcomes. These describe different aspects of the patient's experience. Improvement in quality of life can be valuable even when it is not equivalent to complete continence, and a percentage change in one questionnaire should remain attached to that questionnaire.
What was reported at six months?
At six months, the published summary reported a 15.2-point improvement in ICIQ-LUTSqol in the HIFEM group, described as approximately 35%, compared with a 5.1-point improvement, approximately 13%, in the exercise group. [S12]
The HIFEM group's change was reported as statistically significant, whereas the exercise group's change was not. That pattern is not, by itself, proof of a statistically significant difference between groups. A direct between-group analysis is a separate statistical question. The appropriate wording is that the reported changes were larger in the HIFEM group under the studied conditions, not that all pelvic-floor exercise has been proven inferior.
What was reported at twelve months?
At 12 months, the final abstract reported a 24% improvement in ICIQ-LUTSqol in the HIFEM group and a 3% worsening in the exercise group. It also reported urgency improvement of 32% versus 5%. These are 12-month findings, not three-month results. [S12]
The timepoint is essential. A result measured a year after a course addresses durability differently from a result measured after a few weeks. It should never be shifted to an earlier visit simply to make the treatment appear faster.
These published averages are useful for explaining the study, but incomplete follow-up denominators and limited detail about the exercise programme constrain how precisely they can be translated into an individual treatment decision.
How does newer evidence fit?
A separate sham-controlled pilot published in 2026 studied 40 women receiving pelvic-floor muscle training alongside either active HIFEM or sham HIFEM. It did not find a statistically significant time-by-group interaction in the reported outcomes, despite improvement within groups. That means it did not clearly establish an additional between-group benefit from active stimulation in that pilot. [S17]
This newer study asked a different question: the additional effect of stimulation when both groups received exercise-based care. The device brand was not verified from the accessible abstract, so we refer to it as related HIFEM research rather than automatically treating it as a product-specific EMSELLA trial.
Taken together, the evidence supports a nuanced discussion of protocols, outcomes and patient selection. It does not justify a blanket claim that a chair replaces physiotherapy, nor does one small pilot settle every possible HIFEM protocol.
What should remain central in care?
NICE recommends at least three months of supervised pelvic-floor muscle training as first-line treatment for women with stress or mixed urinary incontinence. That recommendation concerns a structured clinical programme, not merely an instruction to “do some Kegels”. [G02]
A short research comparator should not be presented as equivalent to every form of supervised care. Before choosing a treatment, it is useful to know whether the person can contract and relax the pelvic floor appropriately, what symptoms are being targeted and what has already been tried.
For a ¹EM discussion, practical questions include: “What is the diagnosis?”, “What would the device add to my existing plan?” and “Which outcome will we review?” The answer may include continued exercise, a different assessment, another treatment or no device course at all.
Reading the evidence without turning it into a competition
The value of this article is a clearer treatment conversation. The 12-month study reported encouraging HIFEM outcomes under its protocol. Current guideline-supported care and newer controlled research also belong in that conversation. [S12, S17, G02]
The full funding declaration, detailed exercise protocol and complete participant flow were not verified in the accessible final abstract. This is therefore an evidence explanation with defined source limits, not a comprehensive independent appraisal of every trial method.
Any proposed EMSELLA course still requires device-specific screening and individual assessment. Choosing between or combining approaches should depend on the clinical problem, evidence, preferences and a realistic review plan, rather than a universal “better than exercises” slogan.
Frequently asked questions
Did this study prove EMSELLA is better than all pelvic-floor exercises?
No. It compared HIFEM with one particular exercise programme. The accessible summary does not fully describe supervision, home practice or adherence, and it does not justify a universal superiority claim. [S12]
Was the 24% quality-of-life improvement measured at three months?
No. The final published abstract places the 24% HIFEM improvement and 3% exercise-group worsening at 12 months. [S12]
Why do some summaries say 47 women and others say 38?
The earlier conference summary reported 47, while the final published abstract reports 38. This article uses the final publication and does not invent the missing arm-specific or follow-up counts. [S12]
What does the newer sham-controlled HIFEM pilot add?
The 2026 pilot compared active HIFEM plus pelvic-floor training with sham HIFEM plus the same broad category of training. It did not demonstrate a significant time-by-group interaction, so it did not clearly establish an added between-group benefit in that small study. [S17]
What is an established first-line option for stress or mixed leakage in women?
NICE recommends at least three months of supervised pelvic-floor muscle training. A discussion of EMSELLA should not erase that option or equate it with a few unsupervised contractions. [G02]
Sources
[S12] Guerette N, Molden S, Gopal M, Kohli N. Randomized Trial of HIFEM Pelvic Floor Stimulation Device Compared with Pelvic Floor Exercises for Treatment of Urinary Incontinence. Journal of Women’s Health Care. 12:680. 2023. DOI: 10.35248/2167-0420.23.12.680. https://www.longdom.org/open-access/randomized-trial-of-hifem-pelvic-floor-stimulation-device-compared-with-pelvic-floor-exercises-for-treatment-of-urinary-incontinen-103476.html
[S17] Chan WS et al.. 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. Women’s Health Issues. 36(2):173–180. 2026. DOI: 10.1016/j.whi.2025.12.002. https://pubmed.ncbi.nlm.nih.gov/41582071/
[G02] NICE. Urinary incontinence and pelvic organ prolapse in women: management, recommendations. Guideline NG123. 2019. https://www.nice.org.uk/guidance/ng123/chapter/recommendations
Practical information
Read EMSELLA at ¹EM.
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General educational information, not individual medical advice. Published research findings are not ¹EM patient-outcome data. Suitability, experience and results vary.