Holmium Laser Prostate Surgery, Radical Prostatectomy
Conditions
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).
Interventions
DEVICEEMSELLA®
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.
DEVICESham Comparator 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed