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NCT Number: NCT07580404

Emsella for Reducing tSUI After HOLEP

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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Key information

Conditions

Benign Prostatic Hyperplasia Enlarged Prostate (BPH) Enlarged Prostate With Lower Urinary Tract Symptoms Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location contact

Alyssa McDonald, MPH

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Difference in Michigan Incontinence Score (M-ISI)

    Time frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP

    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.

  2. Difference in International Prostate Symptom Score (IPSS)

    Time frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP

    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).

Secondary outcomes

  1. Difference in safety/adverse effects

    Time frame: 12 weeks post-HoLEP

    Adverse effects reported by patient or detected from hospital and ER admissions within 3 months after procedure.

Other outcomes

  1. Difference in patient reported symptoms

    Time frame: 6 months post-HoLEP

    Patient reported symptoms via REDCap surveys related to gross hematuria, dysuria, incontinence after HoLEP.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa McDonald, MPH

CONTACT

[email protected]

312-695-8146

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

The Utility of Emsella for Reducing Transient Stress Urinary Incontinence (tSUI) Following Holmium Laser Enucleation of the Prostate (HoLEP)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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