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NCT06803602

HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Mayo Clinic
~2,100 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:EMSELLA®Sham Comparator Device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)
Measured over Baseline, 6 weeks, 15 weeks
+1 more outcome measured

Conditions

Holmium Laser Prostate Surgery
Radical Prostatectomy

Explore related trials

Benign Prostatic HyperplasiaProstate Carcinoma

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Mitchell R Humphreys, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Subjects who are male
Post-radical prostatectomy or post HoLEP
Experiencing urinary incontinence one-month post-RP
Have the capacity to make their own medical decisions
Able to complete the questionnaires and visits required.

Exclusion

Subjects who are not male
Not post-radical prostatectomy or post HoLEP
Neurologic disease
Atonic or hypofunctional bladder (bladder contractility index (BCI) \< 100; BCI = pDetQmax+5Qmax)
Status post pelvic radiation
Past surgical history of other GU surgeries
Gross hematuria
Concomitant use of medications that cause muscle relaxation or inhibition
Indwelling foley catheter at time of treatment
Documented urine leak
Not experiencing urinary incontinence
Do not have the capacity to make their own medical decisions
Unable to complete the questionnaires provided.

What this trial measures

  • Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)Baseline, 6 weeks, 15 weeks

    The International Consultation on Incontinence Questionnaire (ICIQ-SF) is a 4-item questionnaire that assesses the frequency, amount, and impact of urinary leakage. The ICIQ-SF has a scoring range of 0-21, with higher scores indicating more severe symptoms.

  • Pad weight testBaseline, 6 weeks, 15 weeks

    For the pad weight test, subjects will be provided with a small scale and asked to measure the weight of their pad before and after wearing for 24 hours.