This study aims to investigate the effectiveness of the Emsella chair treatments at different timepoints. Before and after the holmium laser enucleation of the prostate (HoLEP).
Prostate sizing 80-150g
Ability to independently transfer and tolerate all 30min Emsella treatments (e.g. not wheelchair bound, no mobility issues)
Baseline M-ISI scores <4
Same-day catheter removal and discharge
Catheter dependence
Previous BPH procedure
Previous pelvic surgeries
Pre-existing pelvic floor dysfunction
Parallel
Emsella chair
DeviceEmsella is a non-invasive treatment used to activate and strengthen the pelvic floor. One Emsella treatment is reported to be the equivalent of performing 11,000 Kegel exercises.
Difference in Michigan Incontinence Score (M-ISI)
The Michigan Incontinence Score (M-ISI) is a 10-item questionnaire designed to assess urinary incontinence type, severity, and bother, with a focus on stress and urge incontinence. The tool is commonly used to screen for clinically relevant symptoms, with a total score of greater than or equal to 7 suggesting a need for intervention.
Difference in International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (IPSS) is a 7-question tool (0-35 points) used in urology to assess Benign Prostatic Hyperplasia (BPH) severity, plus one quality-of-life question. It measures symptoms like frequency, urgency, weak stream, and nocturia, with scores of 0-7 (Mild), 8-19 (Moderate), and 20-35 (Severe).
Difference in safety/adverse effects
Adverse effects reported by patient or detected from hospital and ER admissions within 3 months after procedure.
Difference in patient reported symptoms
Patient reported symptoms via REDCap surveys related to gross hematuria, dysuria, incontinence after HoLEP.
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This trial is not recruiting at the moment. You can still explore other options:
