Emsella
intimate health
This unique technology revolutionizes the women's intimate health and wellness category by providing those suffering from incontinence with a completely non-invasive option.
"Every time that my husband and I are intimate since I’ve had the treatment, it has increased the pleasure and the satisfaction. We didn’t have a problem before but he’s like, “yeah, I noticed the difference”. It is a life changer. It has definitely given me more confidence."
★★★★★
"I couldn’t jump rope, I couldn’t do double leg jump. It started there, and it just kind of progressively got worse —sneezing, jumping rope. I can now do them with a lot more confidence than I could before. It’s freeing, very freeing to be able to just do whatever you want to again. I’m 53, and I’m not feeling 53."
★★★★★
What is Emsella?
A breakthrough treatment for incontinence and confidence. This unique technology revolutionizes women’s intimate health and wellness by providing those suffering from incontinence with a completely non-invasive option.
Pelvic floor muscles are the layer of muscles that support the pelvic organs and span the bottom of the pelvis. Strong pelvic floor muscles gives you control over your bladder and bowel. Weakened pelvic floor muscles mean your internal organs are not fully supported and you may have difficulty controlling the release of urine.
How does it work?
EMSELLA utilizes electromagnetic energy to deliver thousands of supramaximal pelvic floor muscle contractions in a single session. These contractions re-educate the muscles of incontinent patients.
Frequently Asked Questions
What is Incontinence?
- Stress incontinence is when there is exerted pressure on the bladder causing leakage. This can be caused by coughing, laughing, sneezing, or exercising
- Urge incontinence is the sudden, intense urge to urinate frequently
- Mixed incontinence is a combination of both stress and urge incontinence
What Causes Urinary Incontinence?
This might be a result of weak pelvic floor muscles since pelvic floor muscles play an important role in supporting pelvic organs and controlling continence. Physiological changes can contribute to the development of urinary incontinence; changes such as vaginal delivery, menopause, and aging can decondition pelvic floor muscles.You will experience tingling and pelvic floor muscle contractions during the procedure. You may resume daily activities immediately after the treatment.
How Long Does an Emsella Treatment Last?
Your provider will tailor a treatment plan for you. A typical treatment takes about 30 minutes and you will need about 6 sessions, scheduled twice a week
What Does an Emsella Treatment Feel Like?
You will experience tingling and pelvic floor muscle contractions during the procedure. You may resume daily activities immediately after the treatment.
How Fast Will I See Results from Emsella treatments?
You may observe improvement after a single session. The results will typically continue to improve over the next few weeks.
clinical studies
PILOT STUDY: HIFEM TECHNOLOGY FOR THE TREATMENT OF URINARY INCONTINENCE
Berenholz J., MD1, Sims T., MD2, Botros G., MD2
- The Laser Vaginal Rejuvenation Institute Of Michigan Farmington Hills, MI, USA
- The Medical Laser and Aesthetics Group, Wirral, United Kingdom
Highlights
- After 6 treatments, 95% of treated patients improved their quality of life according to King’s Health Questionnaire.
- 67% of treated patients reduced or totally eliminated day-to-day use of hygienic pads.
- 100% of patients reported better awareness of pelvic floor muscles.
Design & Methodology
- 30 women (36-76 years) who showed signs of stress, urge, and mixed incontinence took a part in this study.
- Each participant had six therapy sessions total, scheduled twice a week.
- Results were assessed using the King’s Health Questionnaire.
- The number of hygienic pads used and subjective patient feedback was recorded.
- Data was collected pre-, post-treatment, 3-month, and 6-month follow-up.
Results
- After a course of treatment, 67% of treated patients totally eliminated or decreased the average number of hygienic pads used to 0.45 pad per day and night.
- King’s Health Questionnaire Part 2 improved from 37% post-treatment to 57% at 6-month follow-up, showing continuous improvement.
- The results were maintained during the 3- and 6-month follow-ups.
- All patients reported better awareness of their pelvic floor muscles
Figure 5: Patients subjective evaluation of the therapy
Condition:
Level of improvement in the patients’ Quality of Life (QoL) according to the Part 1 and 2 of King Health Questionnaire
HIFEM® PROCEDURE AND ELECTROSTIMULATION FOR TREATMENT OF PELVIC FLOOR MUSCLE WEAKNESS AND URINARY INCONTINENCE
ANALYSIS OF POSTTREATMENT DATA
Elena Silantyeva, MD, PhD1, Dragana Zarkovic, MSc2, Evgeniia Astafeva, MD1, Ramina Soldatskaia, MD1, Mekan Orazov, MD, PhD3, Marina Belkovskaya, MD, PhD1, Mark Kurtser, MD, PhD1.
- Hospital Lapino MD Medical Group, Moscow, Russia
- Charles University, Faculty of Physical Education and Sport, Department of Anatomy and Biomechanics, Prague, Czech Republic 3. RUDN University, Medical Faculty, Moscow, Russia
- Published in Female Pelvic Medicine & Reconstructive Surgery journal: December 19, 2019
Highlights
- 3D ultrasound examination revealed significant improvement of pelvic floor integrity after HIFEM treatment.
- Subjects treated with HIFEM achieved a three times higher level of improvement in PFDI-20 standardized questionnaire.
- Subjects reported two times better results in a subjective evaluation after HIFEM.
- All the assessment methods showed that HIFEM procedure is more effective than electrostimulation for treatment of weakened pelvic floor muscles.
Design & Methodology
- Two groups showing weakened pelvic floor muscles and urinary incontinence were treated with HIFEM (N=50, 31.1 years) and electrostimulation (N=25, 32.0 years).
- One group of healthy patients (N=20, 27.2 years) served as control.
- Treated subjects completed 10 therapies scheduled 2-3 times per week (HIFEM) or every other day (electrostimulation).
- 3D ultrasound was used to quantify the biometric indices of pelvic floor integrity e.g. anteroposterior diameter (LH-AD) and laterolateral diameter (LH-LD) of levator hiatus, hiatal area (HA) and levator-urethra gap (LUG) for pelvic prolapse detection.
- Pelvic Floor Disability Index 20 (PFDI-20) standardized questionnaire and subjective evaluation of subject’s intimate health was assessed.
- Data was collected at the baseline and after completion of treatments.
Results
- HIFEM procedure resulted in significant (P<0.05) improvement in 3D ultrasound measurements, approaching the values of control group after the treatment. Results of electrostimulation group showed similar yet insignificant trend.
- The HIFEM group showed improvement in PFDI-20 questionnaire by 52% (31.45 points), whereas electrostimulation resulted in a change of only 18% (11.78 points).
- The post-treatment difference in PFDI-20 scores between HIFEM and electrostimulation was highly significant.
- Subjects treated with HIFEM reported a decreasing number of urine leakage and improvement in vaginal laxity during intimacy.
- In general, subjective self-evaluation showed a two times higher level of improvement after HIFEM when compared to electrostimulation.
- HIFEM procedure improved integrity of pelvic floor and incontinence while outperforming electrostimulation.
3D Ultrasound measurements of the pelvic floor at the baseline (A) and post-treatments (B) in patient from HIFEM group. Anteroposterior diameter of levator hiatus (red line) and hiatial area (blue line) have been considerably improved after HIFEM.
PELVIC MUSCLES STRENGHTENING BY HIFEM® PROCEDURE AND ELECTROSTIMULATION FOR TREATMENT OF PELVIC FLOOR DYSFUNCTION
Silantyeva Elena MD, PhD, Doctor of Medical Sciences1;
Zarkovic Dragana MSc2; Soldatskaia Ramina MD1; Astafeva Evgeniia MD1, Mekan Orazov MD, PhD3.
- 1. Hospital Lapino MD Medical Group, Moscow, Russia
- Charles University, Faculty of Physical Education and Sport, Department of Anatomy and Biomechanics, Prague, Czech Republic
- RUDN University, Medical Faculty, Moscow, Russia
Highlights
- HIFEM procedure considerably enhanced pelvic floor muscles (PFM) activation in subjects with pelvic floor dysfunction (PFD).
- Subjects were able to produce stronger contractions of greater endurance after HIFEM.
- HIFEM procedure resulted in far greater improvement in PFIQ-7 questionnaire when compared to electrostimulation.
- 36% of HIFEM patients reported a score of 0 on PFIQ-7 after the treatments.
Design & Methodology
- Two groups of post partum women with various PFD symptoms were established and treated by HIFEM (N=50, 1.76 deliveries on average) or electrostimulation (N=25; 1.56 deliveries on average).
- Both treated groups completed 10 therapies according their allocation.
- Electromyographic (EMG) evaluation was used to determine activation of PFM.
- A control group (N=20, 1.25 deliveries on average) was included to determine EMG normative values.
- Pelvic Floor Impact Questionnaire 7 (PFIQ-7) was used to asses life impact of PFD.
- Data was collected at the baseline and after completion of treatments.
Results
- HIFEM significantly (P<0.001) modified PFM activity, since the EMG results of HIFEM group moved towards the values of healthy population.
- The mean change of EMG values after HIFEM ranged from 48% to 59%, while electrostimulation resulted in mild-to-moderate improvement of 7-36%.
- In comparison to electrostimulation, HIFEM patients were able to generate PFM contractions of higher intensity and endurance.
- PFIQ-7 questionnaire showed significantly (P=0.01) more pronounced results in HIFEM group (improved by 57.16%), than in electrostimulation group (improved by 32.18%)
- Additionally, 35.56% of subjects reported zero PFIQ score after HIFEM and almost 90% of subjects from HIFEM group showed none or mild life impact of PFD post treatment.
- HIFEM procedure was substantially more effective in restoration of PFM strength and treatment of PFD in postpartum women when compared to the electrostimulation.
The frequency of PFIQ-7 scores documented in the HIFEM (G1) and electrostimulation (G2) groups. There is a substantial shift towards lower scores in HIFEM group after the treatment; since the scores over 50 were entirely eliminated from responses.
HIFEM® PROCEDURE AND PELVIC FLOOR EXERCISE FOR URINARY INCONTINENCE
Stephanie Molden, MD1
- The Female Pelvic Health Center, Newtown, PA, USA
Highlights
- Initial short-term data demonstrated that patients might benefit either from HIFEM or pelvic floor muscle training (PFMT) procedures for urinary incontinence (UI).
- Preliminary evaluation suggests higher level of improvement after HIFEM procedure.
- HIFEM procedure resulted in considerable reduction of incontinence pads usage.
- Subjects reported positive changes in their quality of life resulting from reduction of UI symptoms and regained control over the PFM muscles.
- HIFEM procedure was found to be more comfortable.
Design & Methodology
- Fifteen subjects with various UI symptoms were recruited and randomly divided into the HIFEM (N=8, 57.4±5.9 years) and PFMT (N=7, 51.9±12.7 years) groups.
- All subjects completed six HIFEM treatments or PFMT sessions performed twice a week for three weeks.
- The same evaluation methodology was used in both groups in regards to comparison of achieved results.
- Subject’s evaluation included various methods: UDI-6, ICIQ-LUTSqol, 3-day ICIQ-BD, Pad Usage, maximal voluntary contraction measurement using biofeedback and digital palpation, therapy comfort and subject satisfaction questionnaire.
- Safety of the HIFEM procedure and pelvic floor exercise was documented.
Results
- Assessment of pelvic floor contractions revealed muscle strength enhancement in both groups which led to improvement of subjects’ continence.
- The HIFEM procedure tended to have a higher impact on subjects by the means of objective and subjective examination.
- The 3-day bladder diary in HIFEM group revealed considerable decrease of pad usage by -1.2 pads/24 hours, reported at 3 months.
- At 3-month follow-up, the average bladder sensation decreased by 38.9% (-0.82 points on 0-4 scale) after HIFEM procedure while PFMT group score returned to its baseline values.
- UDI-6 and ICIQ-LUTSqol questionnaires in both groups indicated clinically significant ups.
- improvement of subject’s quality of life after the treatment and at both completed followups. Subjects found the HIFEM procedure to be more comfortable then exercise.
- Subjects found the HIFEM procedure to be more comfortable then exercise.
- Both treatment modalities showed to be safe, as no adverse events were observed.
- More data with longer follow-up is needed to corroborate the interim results.
Figure: ICIQ-LUTSqol and UDI-6 scores were continuously decreasing in both groups and exceeded minimally clinically important difference of 4 points or 11 points respectively.
FEMALE SEXUAL FUNCTION AND URINARY INCONTINENCE AFTER HIFEM® PROCEDURE
Julene B. Samuels MD, FACS1, Kimberly Evans MD, FACOG2
- Julene B Samuels MD, FACS, Prospect, KY, USA
- Hillcroft Medical Clinic, Sugar Land, TX, USA
Presented at North American Menopause Society 2020 Virtual Annual Meeting
- 31 females (49.8±9.9 years), who showed a decreased interest in sexual activity accompanied by UI, were enrolled in this prospective one-arm study.
- Subjects’ continence and sexual function have been significantly (P<0.001) improved.
- Greatest improvement was seen after 3 months and it was maintained for 6 months: (1) ICIQ-SF overall score decreased on average by 61.6% (-7.0 points); (2) FSFI showed significant increase by 35.5% (+7.9 points); (3) PISQ-12 score increased significantly by 26.3% (+8.4 points)
- Patients benefited from increased sexual desire, improved lubrication, and arousal, and they were also more satisfied with their orgasm intensity.
ICIQ-SF (left) and FSFI (right) scores were significantly (P<0.001) improved after the HIFEM treatments. Red dotted line indicates the threshold for female sexual dysfunction equal to 26.55 points.
HIFEM® FOR MALE URINARY INCONTINENCE
Javier Azparren MD1, Judson Brandeis MD2
- Madina and Azparren Medical Center, Donostia-San Sebastian, Spain
- Male Sexual Medicine and Rejuvenation Center, San Ramon, CA, USA
- Post-prostatectomy incontinence (PPI) is a commonly reported side effect of the radical prostatectomy with prevalence reaching up to 60%a.
- HIFEM procedure significantly enhanced quality of life of men with PPI.
- All subjects achieved improvement after six HIFEM treatments.
- In general, subjects were less limited in their social life, daily activities, physical activities and reported improvement in sleep quality.
- Average pad usage was reduced by 1.0 pad/day.
- Ten elderly men (72.9±3.9 years) with a recent history of radical prostatectomy accompanied with PPI were recruited.
- They underwent six HIFEM treatments scheduled twice a week for three weeks.
- Subject’s Quality of Life (QOL) was assessed by King’s Health Questionnaire (KHQ) at baseline and post-treatment; 1 and 3-month follow-up were optional.
- 24-hour Pad Usage questionnaire was used to identify any changes in the frequency of wearing absorbent pads.
- Adverse events were monitored throughout the study.
Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, Glazener CM. Conservative management for postprostatectomy urinary incontinence. Cochrane Incontinence Group, ed. Cochrane Database Syst Rev. Published online January 20, 2015
STRESS URINARY INCONTINENCE STUDY: 6-MONTH FOLLOW-UP
IN TREATMENT OF STRESS URINARY INCONTINENCE
Alinsod R.1, Vasilev V.2, Yanev K3, Buzhov B.2, Stoilov M.2, Yanev K.3, Georgiev M.3
- South Coast Urogynecology, Laguna Beach, California
- Urology Cabinet ‘Dr. Vasilev’, Sofia, Bulgaria
- Department of Urology, Aleksandrovska University Hospital, Sofia, Bulgaria
Presented at the Annual Meeting of the American Society for Laser Medicine and Surgery, 2018; Dallas, TX
- Quality of life significantly improved in all women after a course of six treatments with HIFEM technology.
- 71% of patients significantly decreased the use of hygienic pads.
- At 6-month follow-up there was a 77% level of improvement in incontinence
- according to KHQ questionnaire.
Results of the King’s Health Questionnaire (KHQ) score; SD = standard deviation.
- 30 women with stress urinary incontinence (classified as SUI type 0-2a), of average age 57.99±10.36 years were enrolled.
- Patients had six therapies scheduled twice a week.
- Quality of life was assessed using King’s Health Questionnaire (KHQ) investigating general health and the impact of incontinence on daily life.
- Additionally, patients were asked to report the number of used hygienic pads per day.
- Data was collected pre-treatment, post-treatment, and at both 3-month and 6-month follow-up.
- There was a 77% level of improvement in incontinence impact according to KHQ at 6-month follow-up.
- The average KHQ score (both parts) was continuously decreasing during the course of study.
- Short and long-term results showed improvement in patients’ quality of life.
- Patients significantly decreased pad usage by 71% and at 6-month follow-up patients only used 1.33 pad per day and night after the treatments.
- The results obtained from this study suggest the HIFEM technology is a promising approach for pelvic floor muscles stimulation that further improves the quality of life among SUI patients.
Use of hygienic pads
QUANTIFICATION OF HIFEM EFFECTS ON URINARY INCONTINENCE
Samuels J., MD1 and Guerette N., MD2
- Julene B. Samuels, MD, FACS, Louisville, KY
- The Female Pelvic Medicine Institute of Virginia, Richmond, VA
Presented at the Annual Meeting of the American Society for Laser Medicine and Surgery, 2018; Dallas, TX
- Quality of life improved in all patients using HIFEM technology, based on King’s Health Questionnaire.
- Nearly 75% of patients significantly decreased urinary leakage or achieved total dryness and maintained these results through 6-month follow-up.
- Patients reached 60% of average improvement in both parts of the King’s Health Questionnaire.
- Majority of patients decreased pad usage to a minimum or totally eliminated them.
- Retrospective, two-site study investigating the effectiveness of HIFEM treatment for urinary incontinence.
- 20 women aged from 45 to 77 years with either stress, urge, or mixed urinary incontinence.
- Study aimed to quantify data as well as the impact on quality of life of incontinent women.
- All patients completed six treatments, delivered twice a week for three consecutive weeks.
- Data was collected using the King’s Health Questionnaire (KHQ) pre-and post-treatment, also at 3 and 6-month follow-up.
- Additionally, patients recorded any urinary leakage episodes and pad usage.
- Improvement was observed in both short- and long-term results based on King’s Health Questionnaire.
- Patients reported decreased frequency of hygienic pad usage, and decreased frequency of urine leakage episodes.
- The post-treatment initial improvement in KHQ averaged as 50% was maintained and further improved up to 60% at the 6-month follow-up.
- 11 patients were pad free at 3-month follow-up.
- Results suggest that treatment with HIFEM technology significantly decreases the negative impact of urinary incontinence on patient’s daily life.
