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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care (Kegel Exercises) | No Intervention | Patients are reminded to perform pelvic floor exercises known as Kegel exercises for 3 weeks leading up to their scheduled HoLEP procedure, and continue Kegel exercises for 3 weeks following the HoLEP procedure. | |
| Pre-HoLEP Emsella | Active Comparator | Participants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) leading up to their scheduled HoLEP procedure. They will undergo the HoLEP 1 week after the final Emsella treatment session. |
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| Post-HoLEP Emsella | Active Comparator | Participants will complete 2 30-minute Emsella treatment sessions for 3 weeks (for a total of 6 30-minute Emsella chair treatment sessions) following their scheduled HoLEP procedure. They will begin their first Emsella treatment session 1 week after HoLEP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emsella chair | Device | Emsella 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP |
| 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). | Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in safety/adverse effects | Adverse effects reported by patient or detected from hospital and ER admissions within 3 months after procedure. | 12 weeks post-HoLEP |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in patient reported symptoms | Patient reported symptoms via REDCap surveys related to gross hematuria, dysuria, incontinence after HoLEP. | 6 months post-HoLEP |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alyssa McDonald, MPH | Contact | 312-695-8146 | alyssa.mcdonald@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy E Krambeck, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| D052801 |
| Male Urogenital Diseases |