A study of women with persistent urinary symptoms after pelvic surgery reported improved symptom scores after HIFEM treatment, but suitability depends on the operation, healing, implants and the current cause of symptoms rather than surgery history alone.
Continence after surgery is not the same as prolapse treatment
A postoperative urinary-symptom study cannot establish that EMSELLA corrects the prolapse itself. Surgical recovery, residual symptoms and any implanted material need individual assessment before treatment is considered.
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Study at a glance
Design: Prospective open-label single-arm postoperative study.
Participants: 50 women enrolled; 49 included in the reported analysis.
Research protocol: Six 28-minute HIFEM sessions, twice weekly over three weeks.
Follow-up: After the course, three months and six months.
Evidence visual: After pelvic surgery: which outcome changed?
Questionnaire points describe symptoms, not a repaired anatomical structure.
Total symptom score
Baseline: 17.4 BFLUTS-SF points; After course: 12.1 BFLUTS-SF points; Three months: 11.9 BFLUTS-SF points; Six months: 12.6 BFLUTS-SF points.
49 analysed participants. Lower is better. Means are shown without mixing standard error and standard deviation.
Incontinence domain
Baseline: 4.9 domain points; Three months: 3 domain points; Six months: 2.8 domain points.
A symptom-domain result. It is not a percentage of prolapse corrected or patients cured.
Individual assessment
Confirm the procedure, healing, implants and current symptom pattern. The study is not an implant-clearance tool or a universal postoperative start date.
Source for the visual: [S14]. Document the symptom being reviewed. Persistent symptoms after surgery require clinical context and appropriate coordination.
A specific postoperative question
Surgery and urinary symptoms do not always have a simple before-and-after relationship. A person may have persistent leakage, urgency or other lower urinary tract symptoms after a prolapse or anti-incontinence procedure. The relevant clinical question is what is causing the current symptoms and whether an additional treatment is appropriate. [S14, G02]
Singhal and Gopal examined HIFEM in this postoperative setting. Their study is useful because it considers women with previous pelvic surgery rather than assuming that a general continence study answers every postoperative question.
The result concerns urinary symptom scores. It is not evidence that an electromagnetic treatment reverses prolapse, repairs an operation or makes every implanted material compatible with treatment.
For treatment background, read Are EMSCULPT NEO and EMSELLA safe?. This article focuses on the specific research question.
Who was included?
Fifty women aged 35 to 80 were enrolled in the study. One participant was excluded for not adhering to the inclusion criteria, leaving 49 in the reported analysis. Participants had a history of pelvic organ prolapse and/or anti-incontinence surgery and ongoing urinary symptoms. [S14]
The protocol used six 28-minute HIFEM sessions, twice weekly over three weeks. Outcomes were assessed after treatment and again at three and six months. This was an open-label, single-arm study, not a randomised comparison against sham or another postoperative intervention. [S14]
The distinction between 50 enrolled and 49 analysed should remain visible. A report's recruitment total is not always the denominator for its results.
What is BFLUTS-SF measuring?
The Bristol Female Lower Urinary Tract Symptoms Short Form, or BFLUTS-SF, records several domains of urinary symptoms and their effect on life. These include filling symptoms, voiding symptoms, incontinence and quality-of-life effects. It also contains a sexual-function domain. Lower scores indicate less reported symptom burden. [S14]
A domain score is different from an anatomical measurement of prolapse severity. Improvement in a symptom questionnaire does not establish that the pelvic support structures have been surgically or mechanically restored.
That is why it is helpful to ask exactly what has improved: leakage, urgency, emptying symptoms or daily impact. The total score summarises several experiences, while the domain scores help locate the change.
What did the total score show?
The study reported a mean combined BFLUTS-SF score of 17.4 at baseline, 12.1 after the treatment course, 11.9 at three months and 12.6 at six months. The follow-up scores therefore remained lower than the baseline score in the analysed group. [S14]
These values should be read as points on the questionnaire. They are not percentages of prolapse corrected, muscle strength restored or patients cured. The modest increase between the three- and six-month means also does not establish an automatic need for retreatment.
The primary publication and earlier supplier summary used different ways of reporting variability around the means. This article displays the means without mixing standard error and standard deviation. Those measures answer different statistical questions and should never be silently substituted in a graphic.
Which symptom domains changed?
The publication reported improvements across several lower urinary tract symptom domains, with prominent changes in incontinence-related symptoms, filling symptoms and quality of life. For example, the mean incontinence-domain score changed from 4.9 at baseline to 3.0 at three months and 2.8 at six months. [S14]
This gives a more specific picture than a broad claim that “pelvic health improved”. It also shows why a review should record the symptom of concern rather than rely exclusively on a total score.
The study does not establish identical benefit after every type of operation or in every severity category. Prior surgery is a clinically important context, not a single uniform diagnosis.
Why the operation details matter
Before considering EMSELLA after surgery, the treating clinician needs to know what procedure was performed, when it occurred, whether healing is complete and whether any implanted devices or materials are present. The relevant device instructions and, where appropriate, the operating clinician's advice are part of that assessment.
The article cannot clear a sling, mesh, artificial sphincter, electronic implant or other material for treatment simply because postoperative patients were included in a study. Material, location, device design and the current medical situation can all matter. The presence of an implant is a reason for specific verification, not a generic yes or no from a research percentage.
Persistent or recurrent symptoms also warrant consideration of their cause. Pain, blood in the urine, voiding difficulty and other concerning features should lead to clinical assessment rather than an automatic device booking. NICE identifies situations requiring further evaluation or specialist referral in women with urinary incontinence. [G02]
What a useful ¹EM review would focus on
A postoperative consultation should establish the current concern and the existing plan of care. Helpful information includes the operation report or a clear procedure history, the timeline of symptoms, relevant medication and the advice already received from the treating team.
A proposed course should identify a measurable goal, an appropriate review point and what would trigger a different assessment. Where urogynaecology, urology or pelvic-health physiotherapy is already involved, a device discussion should support coordination rather than create a separate contradictory plan.
The research offers a reason to explore HIFEM as a possible additional option in selected circumstances. It does not make the device the default answer to every postoperative symptom.
Safety and source context
No adverse events were reported in this study, and the publication declares no conflict of interest. Those statements describe the observed cohort and the authors' declaration; they are not independent proof of every possible commercial relationship or a guarantee of safety in every postoperative patient. [S14]
The study has no concurrent control group, so it cannot separate all possible influences on change over time. Its value is a documented postoperative symptom pattern following the studied course.
The practical conclusion is that treatment may be worth an individual discussion where the current diagnosis, surgical history and device screening support it. The right first step is an assessment, not an assumption that previous surgery either guarantees benefit or automatically rules out all options.
Frequently asked questions
Does this study mean EMSELLA repairs prolapse?
No. The principal outcomes were lower urinary tract symptom questionnaire scores. They do not establish reversal of prolapse or anatomical repair of pelvic support structures. [S14]
Were 50 women included in the final analysis?
Fifty enrolled, but one was excluded for not adhering to the inclusion criteria. The reported analysis included 49 women. [S14]
What happened to the BFLUTS-SF score?
The reported mean total score changed from 17.4 at baseline to 12.1 after treatment, 11.9 at three months and 12.6 at six months. Lower scores indicate less reported symptom burden. [S14]
Can this article confirm that my sling or implant is safe with EMSELLA?
No. The exact implant, its location, the operation, healing and current device instructions require individual review. Inclusion of postoperative patients in a study is not clearance for an unspecified implant.
Can I start immediately after an operation?
This study does not establish a universal postoperative start date. Timing requires assessment of healing, the procedure and the treating team’s advice before device-specific suitability is decided. [S14]
Sources
[S14] Singhal D, Gopal M. HIFEM Procedure for Treatment of Persistent Urinary Incontinence Post-Pelvic Organ Prolapse and Anti-Incontinence Surgery. Journal of Women’s Health Care. 12:701. 2023. DOI: 10.35248/2167-0420.23.12.701. https://www.longdom.org/open-access/hifem-procedure-for-treatment-of-persistent-urinary-incontinence-post-pelvic-organ-prolapse-and-antiincontinence-surgery-105067.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 information cannot determine whether treatment is right for you. Request a private assessment with the ¹EM team.
General educational information, not individual medical advice. Published research findings are not ¹EM patient-outcome data. Suitability, experience and results vary.