HIFEM Technology for Post-Prostate Surgery

Overseen By Mitchell R Humphreys, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Muscle relaxants

Disqualifiers: Neurologic disease, Atonic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called High-Intensity Focused Electromagnetic (HIFEM) technology to help men regain urinary control and enhance their quality of life after prostate surgery. Participants will join one of two groups: one will receive actual HIFEM treatment, while the other will receive a placebo treatment for comparison. The trial seeks men who have undergone prostate surgery and experience urinary leakage one month afterward. As an unphased trial, this study allows participants to contribute to innovative research that could improve post-surgery recovery for many.

Will I have to stop taking my current medications?

The trial excludes participants who are using medications that cause muscle relaxation or inhibition, so you may need to stop taking such medications to participate.

What prior data suggests that HIFEM technology is safe for post-prostate surgery recovery?

Research has shown that High-Intensity Focused Electromagnetic (HIFEM) technology is safe for people. In past studies, HIFEM therapy significantly helped men with urinary incontinence after prostate surgery, improving symptoms without major side effects.

Another study on the Emsella device, which uses HIFEM technology, found it safe and effective for men recovering after prostate surgery. Participants experienced better urinary control and quality of life, with no serious negative effects reported.

Overall, evidence suggests that HIFEM technology is well-tolerated and can be a safe option for improving recovery after prostate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HIFEM Technology for post-prostate surgery recovery because it offers a non-invasive treatment option using high-intensity focused electromagnetic (HIFEM) energy. This technology targets and strengthens pelvic floor muscles, potentially reducing urinary leakage without the need for surgery or medication. Unlike traditional options like pelvic floor exercises or medications, HIFEM can provide results in a much shorter timeframe with just a few sessions. This innovative approach could offer a more convenient and effective solution for individuals seeking to improve their quality of life after prostate surgery.

What evidence suggests that HIFEM technology is effective for improving recovery after prostate surgery?

Research has shown that High-Intensity Focused Electromagnetic (HIFEM) technology can improve urinary control after prostate surgeries. One study found that HIFEM strengthens pelvic muscles, reducing urine leakage post-surgery. Another study reported that HIFEM enhanced the quality of life for men with urinary issues after surgery. Patients who used HIFEM noticed improvements in urinary symptoms and overall well-being. In this trial, participants in the treatment group will receive HIFEM sessions using the Emsella device, while those in the placebo group will receive sessions with a sham comparator device. These findings suggest that HIFEM can effectively aid recovery after surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Mitchell R Humphreys, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for men recovering from radical prostatectomy or Holmium laser prostate surgery who are looking to improve urinary control and quality of life. Specific eligibility criteria details were not provided.

Inclusion Criteria

Able to complete the questionnaires and visits required.

I am male.

I have had surgery to remove my prostate.

Exclusion Criteria

Documented urine leak

I have had surgery on my urinary or genital organs before.

I am not male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2, 30-minute sessions weekly for 3 weeks using the Emsella device or a sham comparator device

3 weeks

6 visits (in-person)

Wash-out

A 1-week wash-out period where no treatment is administered

1 week

Optional Extension

Participants experiencing urinary leakage may continue or cross-over to active treatment for an additional 3 weeks

3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HIFEM Technology

Trial Overview The study tests High-Intensity Focused Electromagnetic (HIFEM) technology, using the EMSELLA® device, against a sham comparator to see if it speeds up recovery of urinary function post-surgery.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects randomized to the treatment group will receive 2, 30-minute sessions, weekly for 3 weeks using the Emsella device. After a 1 week wash-out period, subjects still experiencing urinary leakage will have the option to continue treatment for 3 additional weeks.

Group II: Placebo Group Placebo Group 1 Intervention

Subjects randomized to the placebo group will receive 2, 30-minute sessions, weekly for 3 weeks using a sham comparator device. After a 1 week wash-out period, subjects in the placebo group who are experiencing urinary leakage will be offered the opportunity to cross-over to an active treatment group for an additional 3 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

High-intensity focused ultrasound (HIFU) shows promising efficacy in treating localized and locally advanced prostate cancer, with biochemical disease-free survival rates ranging from 78% to 84% at 1 year and 45% to 84% at 5 years across 20 studies involving 3018 patients.

Despite its potential, the overall quality of evidence for HIFU's efficacy and safety is considered very low due to the lack of controlled study designs, indicating a need for further research to validate its effectiveness and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the efficacy and safety of high-intensity focussed ultrasound for the primary and salvage treatment of prostate cancer. Warmuth, M., Johansson, T., Mad, P.[2022]

Transrectal high-intensity focused ultrasound (HIFU) is a safe and minimally invasive treatment for elderly men with prostate cancer, with a significant reduction in major adverse events over time, such as rectal mucosa burns decreasing from 15% to 0%.

The treatment showed a notable decrease in urinary tract infections, from 58% initially to only 8% in later treatments, indicating improved safety and efficacy in managing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound: complications and adverse events. Thüroff, S., Chaussy, C.[2004]

High Intensity Focused Ultrasound (HIFU) and brachytherapy both show safety in treating localized prostate cancer, with no significant differences in long-term cancer-specific survival rates, based on a study comparing matched patient groups.

However, brachytherapy resulted in better outcomes regarding urinary symptoms and biochemical recurrence-free survival, indicating it may be a more effective option for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Intensity Focused Ultrasound versus Brachytherapy for the Treatment of Localized Prostate Cancer: A Matched-Pair Analysis. Aoun, F., Limani, K., Peltier, A., et al.[2020]

Robotic high intensity focused ultrasound (HIFU) is a non-invasive and precise treatment for prostate cancer, offering a bloodless alternative to traditional surgical methods.

Since its introduction in the 1990s, HIFU has become a widely used therapy for localized prostate cancer, often combined with other procedures to enhance effectiveness and minimize side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transrectal high-intensity focused ultrasound for local treatment of prostate cancer: current role. Chaussy, CG., Thüroff, S.[2017]

High intensity focused ultrasound (HIFU) can be affected by the presence of fiducial markers implanted during external beam radiation therapy, leading to decreased focal intensity and altered treatment delivery.

Simulations showed that markers positioned within 5 mm of the HIFU focus significantly distort the ultrasound beam, potentially resulting in areas of undertreatment and overtreatment, indicating a need for reevaluation of marker placement protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beam distortion due to gold fiducial markers during salvage high-intensity focused ultrasound in the prostate. Georgiou, PS., Jaros, J., Payne, H., et al.[2022]

High-intensity focused ultrasound (HIFU) is emerging as a promising alternative therapy for organ-confined prostate cancer and can also be used for local recurrence after radiation therapy.

HIFU shows comparable oncological outcomes to established salvage treatments for radiation-recurrent prostate cancer, with the potential for fewer side effects, making it a viable option for low-to-intermediate-risk cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current role of high-intensity focused ultrasound for the management of radiation-recurrent prostate cancer. Sountoulides, P., Theodosiou, A., Finazzi-Agró, E.[2017]

High-Intensity Focused Ultrasound (HIFU) has been explored for treating prostate cancer, but the evidence is limited to case series with no randomized studies, and follow-up durations are generally short, averaging less than 2 years.

The treatment has significant toxicity risks, including high rates of impotence (44%-61%) and varying rates of incontinence (0%-14%), leading to the conclusion that HIFU should only be used in research settings until more robust efficacy data is available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology review: high-intensity focused ultrasound for prostate cancer. Pickles, T., Goldenberg, L., Steinhoff, G.[2005]

High-intensity focused ultrasound (HIFU) is a safe and effective minimally invasive treatment for localized prostate cancer, achieving an 84.2% biochemical success rate in low and intermediate-risk patients after a mean follow-up of 67.9 months.

While HIFU shows promise, especially for low and intermediate-risk patients, its effectiveness decreases in high-risk patients, with only a 43.1% success rate, indicating that it may not be suitable for all prostate cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound (HIFU) in prostate cancer: a single centre experience in patients with low, intermediate or high-risk of progression. Callea, A., Piccinni, R., Zizzi, V., et al.[2016]

Contrast-enhanced ultrasound (CEUS) is a valuable tool for assessing treatment effects immediately after focal high intensity focused ultrasound (HIFU) for localized prostate cancer, showing a significant agreement with early multiparametric MRI (mpMRI) results.

In this study of 32 men, CEUS guided further ablation in 39% of cases and demonstrated a higher negative predictive value compared to mpMRI, suggesting it may enhance the efficacy of HIFU in ruling out clinically significant cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of intraoperative contrast-enhanced ultrasound in detecting residual disease after focal HIFU for localized prostate cancer. Bacchetta, F., Martins, M., Regusci, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12407011/

Evaluating the Efficacy of High-Intensity Focused ... This study demonstrated that HIFEM technology can be safely and effectively used to prevent PPI by strengthening the PFM in a varied patient ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06372704

Study Details | NCT06372704 | Is the HIFEM Procedure an ... This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic technology used therapeutically in patients with urinary ...

3. longdom.org longdom.org/open-access/hifem-procedure-enhances-the-quality-of-life-in-elderly-men-with-postprostatectomy-incontinence-a-pilot-study-105398.html

HIFEM Procedure Enhances the Quality of Life in Elderly ... This pilot study investigating the therapeutic effects of the HIFEM procedure in a male population has shown a significant improvement in all domains of QoL.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10112049/

Conservative interventions for managing urinary incontinence ... PFMT improves bladder outlet resistance, which is confirmed by both subjective and objective tests, with a reduction in the volume, symptoms and bother of ...

5. theurologyplace.com theurologyplace.com/emsella-efficacy

Tired of Incontinence? Our office utilizes HIFEM technology through Emsella which is also known as the kegel throne. This non-invasive treatment can help you get ...

6. mdtw.co mdtw.co/emsella-recovery-after-prostate-surgery/

Emsella For Recovery After Prostate Surgery Recover faster after prostate surgery with Emsella® in Brea, CA. Strengthen pelvic muscles, reduce incontinence, and restore sexual function safely.