Emsella for Reducing tSUI After HOLEP

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07580404
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

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.

Study Details

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).

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Standard Care (Kegel Exercises)
    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.
  • Active Comparator: Pre-HoLEP Emsella
    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.
  • Active Comparator: Post-HoLEP Emsella
    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.

Primary Outcome Measure

Difference in Michigan Incontinence Score (M-ISI) [ Time Frame: Pre-HoLEP, 4 weeks, 6 weeks, 8 weeks, 12 weeks post-HoLEP ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Alyssa McDonald, MPH

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By research site
Northwestern University· Chicago, IL

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