A small follow-up summary of 11 women reported lower urinary symptom scores at one year than at baseline, with some improvement receding after six months; it cannot establish a universal duration of benefit or maintenance schedule.
Follow-up is an observation, not a promise
The participant count and questionnaire result at each follow-up belong together. A one-year observation does not guarantee the same duration for everyone or establish a universal maintenance schedule.
Measuring pelvic-floor progress: what is useful to track? · How Many EMSELLA Sessions Are Recommended?
Study at a glance
Design: Conference-follow-up summary of a small subset, not a new controlled trial.
Participants: 11 women from the earlier cohort; five baseline pad users.
Research protocol: Follow-up after the original six-session pelvic-floor HIFEM course.
Follow-up: Confirmed numerical timepoints: baseline, six months and one year.
Evidence visual: Follow-up is not a maintenance prescription
Only the timepoints with verified numerical values are shown.
Symptom follow-up
Baseline: 11.09 ICIQ-SF points; Six months: 5.33 ICIQ-SF points; One year: 7 ICIQ-SF points.
Eleven-person follow-up subset. Lower score is better. Discrete observations, not a continuously measured curve.
Pad-user subset
Baseline: 3 pads per day; One year: 1.4 pads per day.
Only five women used pads at baseline. Do not apply this denominator to all eleven or to the original 75-person study.
Evidence status
BTL summary of a conference abstract accepted for ASLMS 2020. Not a retrieved full peer-reviewed long-term paper; no optimal maintenance interval was tested.
Source for the visual: [S13]. Source format and small subgroup size matter. Review returning symptoms before recommending further treatment.
The question after the treatment course
When a treatment helps, the next practical question is often how long that benefit may last. The answer needs actual follow-up data, not an assumption that a short-term improvement is permanent. A small report by Samuels followed women beyond their original EMSELLA course and provides one observation of that longer-term pattern. [S13]
The report is useful because it includes a one-year review. Its size and source format are equally important: this article is based on a BTL two-page summary of a conference abstract accepted for ASLMS 2020, not a separately retrieved full peer-reviewed long-term paper.
That distinction is part of the evidence, not fine print. Readers should know exactly what kind of source is being explained.
For treatment background, read Are EMSCULPT NEO and EMSELLA safe?. This article focuses on the specific research question.
Where did these eleven participants come from?
The follow-up involved 11 women who had participated in the earlier multicentre HIFEM study. They had received the original course of six pelvic-floor treatments. The follow-up group included women with stress, urge and mixed urinary incontinence. [S13]
These 11 women were a subset of the earlier cohort, not 11 additional participants in an independent randomised trial. Their outcomes should not be added to the original study as though they represented a separate confirmation in a new population.
The source summary does not provide a complete account of why these particular women contributed long-term follow-up. That limits how confidently the pattern can be generalised to every person who began treatment.
What did the symptom scores show?
The reported mean ICIQ-SF score was 11.09 at baseline, 5.33 at six months and 7.00 at one year. Lower scores indicate less reported symptom burden. The group therefore remained improved relative to baseline at one year, although its mean score had increased between six and twelve months. [S13]
There are two clinically useful observations here. Improvement was still present in the small group at one year, and the pattern was not a straight line of continuing improvement. Both belong in a realistic discussion of durability.
The summary describes post-course and three-month assessments as well, but this article does not invent exact numerical values from the appearance of a chart. The accompanying visual plots only the three values confirmed in the written source. It does not insert a smooth curve or imply that the intervening months were continuously measured.
What happened among women who used pads?
Five women in this long-term subset used pads at baseline. Mean use in that small pad-user group was reported as 3.0 pads per day at baseline and 1.4 at one year. Four of those five women reported reduced use. [S13]
These figures concern five baseline pad users, not all 11 women and not all 75 participants in the original multicentre study. Keeping that denominator visible prevents a small practical observation from becoming a misleading large-cohort success claim.
As in other continence research, pad use and symptom score capture different aspects of the experience. A change in one should not automatically be described as complete continence or assigned to everyone in the study.
Does this tell us when maintenance is needed?
The summary suggests that some patients might benefit from a maintenance discussion around one year. It did not test different maintenance schedules, randomly allocate participants to top-up treatment or identify the optimal interval for a new patient. [S13]
A review at a planned interval and an automatic maintenance purchase are different decisions. The first checks whether the original goal has improved, remained stable or changed. The second presumes further treatment is needed before that assessment occurs.
For ¹EM, the better principle is to agree on a review plan and reassess symptoms before recommending another course. The study supports discussing durability; it does not validate a universal instruction to repeat treatment every six or twelve months.
How should returning symptoms be interpreted?
A return of leakage should be assessed in its current clinical context, rather than assumed to mean the original device effect has simply worn off. The symptom pattern, relevant history and other possible causes still matter. NICE's assessment approach emphasises characterising the type of incontinence and identifying features that require further evaluation. [G02]
The practical question is not only “do I need more EMSELLA?” It is also “is this the same problem, and what is the most appropriate next step now?” That may lead to a review of the existing plan, pelvic-floor care, investigation or referral.
A treatment record is most helpful when it documents a baseline and uses comparable follow-up measures. Repeating the same symptom measure and recording meaningful daily goals can make the review more informative than relying on a remembered impression alone.
How does this fit with other follow-up research?
The separate HIFEM-versus-exercise study also reports outcomes through twelve months, but it uses a different cohort and a different principal quality-of-life questionnaire. Its numbers should not be merged with the ICIQ-SF values discussed here. [S12, S13]
Different studies can contribute to the same clinical question while remaining distinct evidence sources. There is no defensible single duration guarantee obtained by averaging their percentages or selecting the most favourable timepoint from each.
The modest but useful takeaway is that longer-term benefit has been reported in some followed participants. The exact likelihood, size and duration of benefit for an individual remain uncertain.
Source transparency
The verified source for the numerical values in this article is the BTL summary held in the ¹EM reference collection. It identifies a conference abstract accepted for ASLMS 2020. A verified public link to that exact original abstract and a complete funding statement were not available for this rebuild. [S13]
The earlier 2019 full paper is background to the cohort; linking to it alone would not substantiate the one-year numbers. The references therefore distinguish the original clinical paper from the subsequent supplier-held follow-up summary.
This report is best used to support a measured conversation about follow-up. A personal review plan is more useful than a promise that treatment lasts a fixed number of months.
Frequently asked questions
Did all 75 women in the original EMSELLA study return at one year?
No. The long-term summary discussed here reports a subset of 11 women. It should not be described as complete one-year follow-up of all 75 original participants. [S13]
What happened to the symptom score at one year?
Mean ICIQ-SF was reported as 11.09 at baseline, 5.33 at six months and 7.00 at one year. The group remained improved relative to baseline, with some receding of improvement after six months. [S13]
Does this prove I need a maintenance session every year?
No. The report did not compare maintenance schedules or establish an optimal interval. Further treatment should follow reassessment rather than an automatic rule derived from this small subset. [S13]
How many women contributed the pad-use result?
Five women used pads at baseline in this follow-up subset. Their mean use was reported as 3.0 pads per day at baseline and 1.4 at one year. That is a five-person subgroup result. [S13]
Is this a full published one-year clinical paper?
The verified source is a BTL summary of a conference abstract accepted for ASLMS 2020. A full independently retrieved long-term paper or verified public link to the exact original abstract was not available for this article. [S13]
Sources
[S13] Samuels JB. Non-invasive high-intensity focused electromagnetic (HIFEM) procedure for treatment of urinary incontinence: 6 months and 1 year follow-up data. Conference abstract accepted for ASLMS 2020; BTL two-page study summary. 2020. Source basis: BTL study summary held in the ¹EM reference collection. A verified public link to the exact original abstract was not available.
[S11] Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers in Surgery and Medicine. 51(9):760–766. 2019. DOI: 10.1002/lsm.23106. https://pmc.ncbi.nlm.nih.gov/articles/PMC6851770/
[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
[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
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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.