2100 Participants Needed

HIFEM Technology for Post-Prostate Surgery

MR
Overseen ByMitchell R Humphreys, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment HIFEM Technology for post-prostate surgery?

High-intensity focused ultrasound (HIFU), a similar technology, is considered a promising treatment for prostate cancer, offering comparable outcomes to other treatments with potentially fewer side effects, especially in cases of cancer recurrence after radiation therapy.12345

How is HIFEM Technology different from other treatments for post-prostate surgery?

HIFEM Technology is unique because it uses high-intensity focused electromagnetic fields to stimulate muscle contractions, which is different from traditional treatments that may involve surgery or medication. This non-invasive approach can help improve muscle strength and function without the need for incisions or drugs.46789

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of High-Intensity Focused Electromagnetic (HIFEM) technology in improving the recovery time of urinary control and quality of life for male patients after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP).

Research Team

MR

Mitchell R Humphreys, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I have had surgery on my urinary or genital organs before.
Documented urine leak
I am not male.
See 10 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 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 GroupPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

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.
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]
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.
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]
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.
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]

References

High Intensity Focused Ultrasound versus Brachytherapy for the Treatment of Localized Prostate Cancer: A Matched-Pair Analysis. [2020]
The utility of intraoperative contrast-enhanced ultrasound in detecting residual disease after focal HIFU for localized prostate cancer. [2021]
Beam distortion due to gold fiducial markers during salvage high-intensity focused ultrasound in the prostate. [2022]
High-intensity focused ultrasound: complications and adverse events. [2004]
The current role of high-intensity focused ultrasound for the management of radiation-recurrent prostate cancer. [2017]
Technology review: high-intensity focused ultrasound for prostate cancer. [2005]
Transrectal high-intensity focused ultrasound for local treatment of prostate cancer: current role. [2017]
High-intensity focused ultrasound (HIFU) in prostate cancer: a single centre experience in patients with low, intermediate or high-risk of progression. [2016]
Systematic review of the efficacy and safety of high-intensity focussed ultrasound for the primary and salvage treatment of prostate cancer. [2022]
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