Does EMSELLA help urinary incontinence? What the multicentre clinical study found

A multicentre study of 75 women reported improvements in urinary symptoms after six EMSELLA treatments, with separate analysis groups for symptom scores and pad use; these findings support an individual assessment rather than a guaranteed outcome.

A symptom-score change, a change in pad use and a quality-of-life outcome measure different things. A quality-of-life improvement percentage is not the percentage of people cured.

Measuring pelvic-floor progress: what is useful to track?

Design: Prospective multicentre, open-label, single-arm clinical study.

Participants: 75 women enrolled; symptom-score analysis n=61; baseline pad-user analysis n=43.

Research protocol: Six 28-minute HIFEM sessions, twice weekly for three weeks.

Follow-up: After the course and at three months.

Choose the outcome before reading the percentage.

Enrolled: 75 women; Symptom analysis: 61 women; Baseline pad users: 43 women.

These are different denominators, not three independent studies or sequential success rates.

Baseline: 10.57 ICIQ-SF points; After course: 5.33 ICIQ-SF points; Three months: 4.16 ICIQ-SF points.

Reported analysis n=61. Lower scores indicate less symptom burden. The paper separately reports mean improvement of 64.42%; this is not a newly calculated change between the displayed group means.

Baseline: 2.47 pads per day; After course: 1.35 pads per day; Three months: 1.19 pads per day.

Baseline pad users n=43. At three months, 19/43 reported no pad use. Pad-free status is not automatically complete continence.

Source for the visual: [S11]. Keep 75 enrolled, 61 symptom-analysis participants and 43 baseline pad users distinct. Study group averages are not personal predictions.

Urinary leakage can change the way a person plans exercise, travel, work and ordinary activities. Research is most useful when it looks beyond the treatment experience and measures whether symptoms and their daily impact change. The multicentre EMSELLA study by Samuels and colleagues did this using a symptom questionnaire and a record of pad use. [S11]

Published in Lasers in Surgery and Medicine in 2019, the study provides an early clinical account of pelvic-floor HIFEM treatment in women. The encouraging finding was an improvement in the outcomes the investigators followed. Understanding the size and meaning of that improvement requires keeping the different analysis groups clear.

For treatment background, read Are EMSCULPT NEO and EMSELLA safe?. This article focuses on the specific research question.

Seventy-five women enrolled. The study included 37 women described as having stress urinary incontinence, 30 with mixed symptoms and eight with urge incontinence. Their mean age was approximately 55 years. They received six 28-minute HIFEM treatments, scheduled twice weekly over three weeks, with a further assessment three months after the course. [S11]

Stress leakage, urgency-related leakage and mixed symptoms are not interchangeable diagnoses. Including several symptom patterns broadens the clinical questions the study raises, but it does not establish identical effectiveness for every subtype. The urge-only group, for example, contained just eight women. [S11]

The study was prospective and open-label, without a concurrent sham group. Participants knew they were receiving treatment. That makes it a useful before-and-after clinical observation, rather than a blinded test against an inactive procedure.

The International Consultation on Incontinence Questionnaire Short Form, commonly called ICIQ-SF or ICIQ-UI SF, asks about leakage frequency, the amount leaked and its impact. A lower total score generally indicates less severe reported incontinence. It is a structured patient-reported measure, not an MRI measurement of pelvic-floor muscle size. [S11]

In the study's symptom analysis, the mean score fell from 10.57 at baseline to 5.33 after treatment and 4.16 at three months. The paper reported a 64.42% mean improvement at three months. Crucially, the symptom-results table identifies an analysis group of 61 women, rather than presenting these figures as a complete outcome for all 75 enrolled. [S11]

The reported percentage is not reproduced by simply calculating the percentage difference between the displayed group means. Different aggregation methods can produce different percentages. Without individual-level data, this calculation cannot be reconstructed here. We retain the authors' number as reported and also show the raw group scores so readers can see what was measured.

Forty-three women used absorbent pads at baseline. In that subgroup, mean daily use changed from 2.47 pads before treatment to 1.35 after the course and 1.19 at three months. The authors reported a 53.68% mean decrease in pad use at three months. [S11]

Nineteen of those 43 baseline pad users reported no pad use at the three-month assessment. This is the origin of the often-quoted 44.19% figure: 19 out of 43 baseline pad users, not 44.19% of all 75 women. A statement that someone stopped using pads is also not automatically the same as proving complete absence of every leakage episode. [S11]

Pad use is a practical outcome, but it reflects more than urine volume alone. Someone may change pads for comfort, precaution or different activities. It is useful alongside symptom history and a questionnaire, not as a replacement for those measures.

There are three distinct numbers to keep in view: 75 women enrolled, 61 in the reported symptom-score analysis and 43 baseline pad users. These groups answer different questions. The study should not be summarised as though every percentage applies to everyone who started. [S11]

For an individual considering treatment, the most useful message is not a headline “success rate”. It is that improvements were documented in the analysed groups, while the design and reporting do not provide a precise personal probability of becoming dry.

The ¹EM visual accompanying this article keeps those groups separate. Selecting a symptom result shows its score and denominator. Selecting the pad result shows the pad-user subgroup. It never converts the study into a forecast for the reader.

A practical assessment starts with what happens: leakage with coughing or exertion, a sudden urgency that is difficult to defer, a mixture of both, or another pattern. It also considers onset, medications, previous surgery, infection symptoms and other relevant history. Persistent urinary symptoms deserve a clinical explanation before treatment selection. [G02]

At ¹EM, useful review goals could include fewer episodes during an activity, reduced reliance on pads or less interference with daily plans. The agreed measure should match the concern. A baseline symptom record and consistent follow-up can make the discussion more specific than simply asking whether the treatment “worked”.

Pelvic-floor muscle training remains an important established option. NICE recommends a supervised programme of at least three months as first-line treatment for women with stress or mixed urinary incontinence. A discussion of EMSELLA should sit alongside appropriate conservative care rather than imply that learning muscle control is irrelevant. [G02]

The investigators reported no adverse events and described minor transient muscle fatigue in some participants. This is reassuring within the study, but it cannot establish universal safety or rule out uncommon effects. Treatment was offered at a discounted rate to participants. The study should not be presented as independently verified evidence free of commercial context. [S11]

Suitability requires the current device-specific screening process, particularly when pregnancy, implanted devices, metal, previous procedures or other medical circumstances are relevant. A study enrolment checklist is not an individual clearance decision.

The clinical message is constructive: the study documented meaningful changes in patient-reported outcomes in its analysed groups. The next step is to establish whether the treatment and the outcome being measured are relevant to the person seeking care.

Seventy-five enrolled. The paper reports the main symptom-score analysis for 61 women and the pad-use analysis for 43 women who used pads at baseline. These denominators must not be interchanged. [S11]

No. Nineteen of 43 baseline pad users reported no pad use at three months, which is 44.19% of that subgroup. It is not a cure rate for all 75 women or a prediction for a new patient. [S11]

The reported analysis-group mean ICIQ-SF score changed from 10.57 at baseline to 5.33 after treatment and 4.16 at three months. Lower scores indicate less reported symptom burden. [S11]

No. This was an open-label before-and-after study. It documented changes after treatment but did not include a concurrent sham group. [S11]

Not on the basis of this study. Supervised pelvic-floor muscle training remains a first-line option for women with stress or mixed urinary incontinence, and the appropriate combination of care should be discussed individually. [G02]

[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/

[G02] NICE. Urinary incontinence and pelvic organ prolapse in women: management, recommendations. Guideline NG123. 2019. https://www.nice.org.uk/guidance/ng123/chapter/recommendations

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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.