Emsella for Reducing tSUI After HOLEP

NCT07580404 | Not Yet Recruiting FDA Device

• 1 other identifier: STU00225227
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Benign Prostatic Hyperplasia; Enlarged Prostate With Lower Urinary Tract Symptoms; Enlarged Prostate (BPH)

Keywords

HoLEP; Emsella

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Difference in safety/adverse effects

  12 weeks post-HoLEP

Other Outcomes (1)

• Difference in patient reported symptoms

  6 months post-HoLEP

Study Arms (3)

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.

Device: Emsella chair

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.

Device: Emsella chair

Interventions

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.

Post-HoLEP Emsella; Pre-HoLEP Emsella

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to read, understand, and complete surveys and questionnaires

You may not qualify if:

• Catheter dependence
• Previous BPH procedure
• Previous pelvic surgeries
• Pre-existing pelvic floor dysfunction
• Neurogenic bladder
• Overactive bladder - e.g. prescribed and taking any oxybutynin or mirabegron
• Preoperative pad-use for incontinence

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Amy E Krambeck, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa McDonald, MPH

CONTACT

312-695-8146; alyssa.mcdonald@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Endourology/Stone Division

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)