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Enrolling by Invitation

NCT Number: NCT06803602

HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery

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).

Enrolling by Invitation

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Key information

Conditions

Holmium Laser Prostate Surgery Radical Prostatectomy

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are male
  • Post-radical prostatectomy or post HoLEP
  • Experiencing urinary incontinence one-month post-RP
  • Have the capacity to make their own medical decisions
  • Able to complete the questionnaires and visits required.

Exclusion criteria

  • Subjects who are not male
  • Not post-radical prostatectomy or post HoLEP
  • Neurologic disease
  • Atonic or hypofunctional bladder (bladder contractility index (BCI) < 100; BCI = pDetQmax+5Qmax)
  • Status post pelvic radiation
  • Past surgical history of other GU surgeries
  • Gross hematuria
  • Concomitant use of medications that cause muscle relaxation or inhibition
  • Indwelling foley catheter at time of treatment
  • Documented urine leak
  • Not experiencing urinary incontinence
  • Do not have the capacity to make their own medical decisions
  • Unable to complete the questionnaires provided.

Treatment and study plan

EMSELLA®

Device

Subjects will receive 100% intensity of the EMSELLA® (BTL Industries, Marlborough, MA) High-Intensity Focused Electromagnetic (HIFEM) treatment, in a single 30-minute session, twice per week for 3 weeks.

Sham Comparator Device

Device

Subjects will be asked to sit on the EMSELLA® (BTL Industries, Marlborough, MA) treatment head which will be powered off and instead have a small remote control vibration device that will simulate active treatment, in a single 30-minute session, twice per week for 3 weeks.

Primary outcomes

  1. Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)

    Time frame: Baseline, 6 weeks, 15 weeks

    The International Consultation on Incontinence Questionnaire (ICIQ-SF) is a 4-item questionnaire that assesses the frequency, amount, and impact of urinary leakage. The ICIQ-SF has a scoring range of 0-21, with higher scores indicating more severe symptoms.

  2. Pad weight test

    Time frame: Baseline, 6 weeks, 15 weeks

    For the pad weight test, subjects will be provided with a small scale and asked to measure the weight of their pad before and after wearing for 24 hours.

Secondary outcomes

  1. Change in International Prostate Symptom Score (IPSS)

    Time frame: Baseline, 6 weeks, 15 weeks

    The International Prostate Symptom Score (IPSS) is a 7-item questionnaire used to assess urinary symptoms, such as incomplete emptying, frequency, urgency, and weak stream. Each question has six possible answers, ranging from 0 to 5 points, with higher numbers indicating more severe symptoms.

  2. Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF)

    Time frame: Baseline, 6 weeks, 15 weeks

    The Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF) is a 4 item questionnaire to assess the degree of ejaculatory dysfunction in men. The domains include three ejaculatory function items and one ejaculation bother item.

  3. Change in Quality of Life Scale

    Time frame: Baseline, 6 weeks, 15 weeks

    The Quality of Life Scale is a 16-item instrument that measures six domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, recreation, and independence on a scale of 1 to 7 where a low value indicates "terrible" and a high value indicates "delighted". Higher overall scores indicate better quality of life.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Evaluating the Efficacy of High-Intensity Focused Electromagnetic Technology in Improving the Time of Recovery of Urinary Control of Continence and Quality of Life for Post-Surgical Patients

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 31, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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