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

Not Applicable

Not yet recruiting

• Conditions: Holmium Laser Prostate Surgery; Radical Prostatectomy

• Registration Number: NCT06803602
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Study Start: 2025-06-01
• Primary Completion: 2027-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 2100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)	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.
Pad weight test	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 Outcome Measures

Name	Time	Method
Change in International Prostate Symptom Score (IPSS)	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.
Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF)	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.
Change in Quality of Life Scale	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States