Emsella for Reducing tSUI After HOLEP

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07580404

Enrollment

Registered

2026-05-12

Start date

2026-06-01

Completion date

2028-06-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HoLEP, Emsella

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).

Interventions

DEVICEEmsella chair

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Difference in Michigan Incontinence Score (M-ISI)	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.
Difference in International Prostate Symptom Score (IPSS)	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

Measure	Time frame	Description
Difference in safety/adverse effects	12 weeks post-HoLEP	Adverse effects reported by patient or detected from hospital and ER admissions within 3 months after procedure.

Countries

United States

Contacts

CONTACTAlyssa McDonald, MPH

alyssa.mcdonald@northwestern.edu312-695-8146

PRINCIPAL_INVESTIGATORAmy E Krambeck, MD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026