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Not yet recruiting NCT07580404

Emsella for Reducing tSUI After HOLEP

No phase Interventional Benign Prostatic Hyperplasia Enlarged Prostate With Lower Urinary Tract Symptoms Enlarged Prostate (BPH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emsella chair.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms, Enlarged Prostate (BPH). Basic parameters: 50 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Emsella 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.

Primary outcome measures

  • Difference in Michigan Incontinence Score (M-ISI) [Time frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP]
  • Difference in International Prostate Symptom Score (IPSS) [Time frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP]
Secondary outcome measures (1)
  • Difference in safety/adverse effects [Time frame: 12 weeks post-HoLEP]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT07580404 · STU00225227

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗