A ten-man pilot reported improved incontinence-related quality of life and an average reduction of one pad per day after six HIFEM treatments; a later 27-man cohort adds separate short-term evidence, without establishing a guaranteed continence result.
How to interpret the measured result
This small post-prostatectomy pilot describes the men studied and their reported follow-up. It cannot predict an individual recovery timetable after surgery.
Study at a glance
Design: Ten-man uncontrolled pilot, with a separate 2025 male cohort discussed as an update.
Participants: Pilot: ten men, mean age about 73; later cohort: 27 men.
Research protocol: Six 28-minute HIFEM sessions, twice weekly over three weeks.
Follow-up: Pilot main endpoint after course; later cohort after course and one month.
Evidence visual: Male outcomes: quality of life and continence are different
Each percentage stays attached to its questionnaire domain.
Pilot quality of life
Sleep / energy: 53.3 % KHQ-domain improvement; Emotions: 42.5 % KHQ-domain improvement; Social limitations: 42.2 % KHQ-domain improvement.
Ten-man pilot, post-course assessment. These percentages are domain-score changes, not percentages of men cured.
Pilot pad use
Mean reduction: one pad per day. Two of ten men reported no pad use after the course. These are small-pilot observations, not a reliable personal success probability.
Separate 2025 cohort
Baseline: 10.58 ICIQ-SF points; After course: 5.43 ICIQ-SF points; One month: 4.16 ICIQ-SF points.
Tosun et al., 27 men. Separate EMSELLA cohort and a different questionnaire from the KHQ pilot. Lower scores are better.
Source for the visual: [S15, S16, G03]. Do not pool the ten-man KHQ pilot with the 27-man ICIQ-SF cohort or extrapolate these urinary outcomes to erectile function.
Male leakage deserves a male evidence discussion
Urinary incontinence after prostate treatment has its own clinical context. It should not be explained only by borrowing percentages from a study of women. A useful discussion considers the operation, the pattern and severity of leakage, the course of recovery and the existing urological plan. [G03]
The pilot by Azparren and Brandeis specifically studied men with post-prostatectomy incontinence. Its contribution is small but relevant: it records patient-reported quality of life and pad use in a male group after a defined HIFEM course. A later study in 27 men provides another, separate set of short-term observations. [S15, S16]
Neither study makes an individual assessment optional. Together they help identify the questions worth discussing rather than creating a universal result promise.
For treatment background, read EMSELLA after prostate surgery. This article focuses on the specific research question.
Who was in the pilot, and what did they receive?
The pilot included ten men with a mean age of approximately 73 years and urinary incontinence after radical prostatectomy. They received six 28-minute HIFEM sessions, twice weekly over three weeks. The main findings discussed here concern the assessment after the treatment course. [S15]
This was a small prospective pilot without a concurrent control group. Changes during postoperative recovery, individual circumstances and other care cannot be fully separated from the treatment effect using that design alone.
Some later follow-up observations were described for selected individuals. Those should not be presented as complete long-term results for all ten participants.
What did the King's Health Questionnaire measure?
The King's Health Questionnaire, or KHQ, examines the effects of urinary symptoms on several aspects of life. Domains include incontinence impact, role and social limitations, emotions, and sleep or energy. Lower domain scores indicate less reported burden. [S15]
The pilot reported improvements across these domains. The largest relative changes included sleep and energy, 53.3%; emotions, 42.5%; and social limitations, 42.2%. These figures refer to changes in questionnaire-domain scores, not the same percentages of men becoming dry or the same percentage improvement in physical muscle strength. [S15]
For a patient, that distinction is useful. Reduced interference with sleep or social plans can be meaningful, but it is a different outcome from complete continence. A good review can record both symptom control and the activities that matter to the individual.
What happened to pad use?
All ten men were pad users at baseline. The study reported an average reduction of one pad per day after treatment, and two men reported being pad-free at that assessment. [S15]
The two-of-ten observation should remain a count from a very small pilot, not be turned into a reliable “20% cure rate” for a clinic's future patients. Pad-free status itself is not necessarily proof of zero leakage under every condition.
An average reduction of one pad also does not mean every participant reduced use by exactly one. It is a group summary. The most useful individual record would retain baseline use, follow-up use and the circumstances in which leakage occurs.
What does the later twenty-seven-man study add?
A 2025 study by Tosun and colleagues evaluated BTL EMSELLA in 27 men with post-prostatectomy incontinence. Participants received six 28-minute sessions, twice weekly, with assessment after the course and at one month. The reported mean ICIQ-SF score changed from 10.58 at baseline to 5.43 after treatment and 4.16 at one month. No adverse events were reported, and the authors declared no financial or non-financial conflicts. [S16]
This is a separate cohort using a different principal questionnaire from the KHQ pilot. It adds short-term patient-reported symptom evidence, but its scores should not be pooled with KHQ domain percentages or treated as a new arm of the ten-man study.
The study was also uncontrolled. It supports further investigation and an informed clinical conversation, while leaving uncertainty about comparative benefit and longer-term outcomes.
Where does this sit in established postoperative care?
Pelvic-floor muscle training is part of guideline-supported care after prostate treatment. Evaluation of persistent incontinence and appropriate discussion of other treatment options remain important. A device course should not delay specialist assessment when the clinical situation calls for it. [G03]
The relevant question is not whether a person has “failed” at exercises. It is whether the diagnosis is clear, whether the existing programme is appropriate and what additional options are justified by the current problem. The answer may differ according to the severity, timing and type of symptoms.
These HIFEM studies do not establish treatment of prostate cancer, reversal of the operation, recovery of erectile function or equivalence to a male sling or artificial urinary sphincter. Their reported endpoints concern urinary symptoms, related quality of life and pad use. [S15, S16]
What should a ¹EM consultation clarify?
Bring the procedure history, timing of the operation, current urological advice and a description of the leakage pattern. Details of implanted devices or other materials should be reviewed against the applicable device instructions rather than cleared from a general article.
A useful baseline can include a symptom questionnaire and a practical record of pad use or leakage during specific activities. The review should repeat a comparable measure and ask whether the change is meaningful in everyday life.
The treatment discussion should also identify when to return to the urologist or another treating clinician. A coordinated plan is more valuable than a device programme that sits outside the person's postoperative care.
Safety, source limits and the practical takeaway
The pilot reported no treatment-related adverse events in the small group observed. Its full funding and commercial disclosure details were not verified in the accessible abstract and supplier summary. It should not be labelled independent or risk-free on that basis. [S15]
The studies provide male-specific observations that are more relevant to this question than a generic female “success rate”. Their small size, uncontrolled design and limited follow-up still matter. The constructive conclusion is that HIFEM may be a discussion point for selected men within a properly assessed continence plan, not a substitute for that plan.
Frequently asked questions
Were men actually studied, or are the results borrowed from women?
The pilot included ten men with post-prostatectomy incontinence. A later 2025 study included a separate 27-man EMSELLA cohort. These are male-specific observations, although both studies were small and uncontrolled. [S15, S16]
What did the ten-man pilot show about pads?
It reported an average reduction of one pad per day after the course, and two of the ten men reported being pad-free. These observations are not a guaranteed cure probability for a new patient. [S15]
Does 53.3% improvement mean half of the men became dry?
No. The 53.3% figure refers to relative improvement in the sleep/energy domain of the King’s Health Questionnaire. It is not a continence rate or a measure of muscle strength. [S15]
Did the later 27-man study use EMSELLA?
Yes. The 2025 report identifies BTL EMSELLA and reports mean ICIQ-SF scores of 10.58 at baseline, 5.43 after treatment and 4.16 at one month. It is a separate short-term uncontrolled cohort, not an extension of the ten-man pilot. [S16]
Can EMSELLA replace my urologist’s postoperative plan?
No. Individual assessment, pelvic-floor care and appropriate specialist review remain important after prostate treatment. These studies do not establish that a device course replaces other indicated continence care. [G03, S15, S16]
Sources
[S15] Azparren J, Brandeis J. HIFEM Procedure Enhances the Quality of Life in Elderly Men with Post-Prostatectomy Incontinence: A Pilot Study. Medical & Surgical Urology. 13:340. 2024. DOI: 10.35248/2168-9857.24.13.340. https://www.longdom.org/open-access/hifem-procedure-enhances-the-quality-of-life-in-elderly-men-with-postprostatectomy-incontinence-a-pilot-study-105398.html
[S16] Tosun H, Akinsal EC, Bas U, Sonmez G, Baydilli N, Demirci D. Evaluating the Efficacy of High-Intensity Focused Electromagnetic (HIFEM) Therapy for Postprostatectomy Incontinence in Men. Therapeutics and Clinical Risk Management. 21:1309–1315. 2025. DOI: 10.2147/TCRM.S534674. https://pubmed.ncbi.nlm.nih.gov/40909763/
[G03] Sandhu JS et al.; Breyer BN et al.. Incontinence after Prostate Treatment: AUA/SUFU Guideline; read with 2024 AUA/GURS/SUFU amendment. Journal of Urology. 2024. DOI: 10.1097/JU.0000000000004088. https://www.auajournals.org/doi/10.1097/JU.0000000000004088
Practical information
Start with an individual assessment
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.