HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EMSELLA®, Sham Comparator Device.
- Who it may be relevant to
- Registry conditions: Holmium Laser Prostate Surgery, Radical Prostatectomy. Basic parameters: 18 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Device EMSELLA®
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. - Device Sham 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.
Primary outcome measures
- Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) [Time frame: Baseline, 6 weeks, 15 weeks]
- Pad weight test [Time frame: Baseline, 6 weeks, 15 weeks]
Secondary outcome measures (3)
- Change in International Prostate Symptom Score (IPSS) [Time frame: Baseline, 6 weeks, 15 weeks]
- Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF) [Time frame: Baseline, 6 weeks, 15 weeks]
- Change in Quality of Life Scale [Time frame: Baseline, 6 weeks, 15 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Arizona — Scottsdale
Identifiers
NCT: NCT06803602 · 24-010450