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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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. |
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| Placebo Group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) | 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. | Baseline, 6 weeks, 15 weeks |
| Pad weight test | 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. | Baseline, 6 weeks, 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | 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. | Baseline, 6 weeks, 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell R Humphreys, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| 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. |
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| Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF) | 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. | Baseline, 6 weeks, 15 weeks |
| Change in Quality of Life Scale | 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. | Baseline, 6 weeks, 15 weeks |