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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Mayo Clinic
- Enrollment
- 2,100
- Locations
- 2
- Primary Endpoint
- Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
Treatment Group
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.
Intervention: EMSELLA® (Device)
Placebo Group
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.
Intervention: Sham Comparator Device (Device)
Outcomes
Primary Outcomes
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.
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
- Change in International Prostate Symptom Score (IPSS)(Baseline, 6 weeks, 15 weeks)
- Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF)(Baseline, 6 weeks, 15 weeks)
- Change in Quality of Life Scale(Baseline, 6 weeks, 15 weeks)
Investigators
Mitchell Humphreys
Principal Investigator
Mayo Clinic