Benign Prostatic Hyperplasia
Conditions
Brief summary
To determine if early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic HoLEP.
Interventions
PROCEDUREEAR HoLEP
early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia
PROCEDUREClassic HoLEP
classic holmium enucleation of the prostate as a surgical treatment for benign prostatic hyperplasia
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be 18 years of age or older * Patients must present to clinic with a diagnosis of benign prostatic hyperplasia * Patients must be scheduled to undergo a holmium laser enucleation of the prostate
Exclusion criteria
* Patients with previous surgical management of BPH * Patients with prostate biopsy revealing high risk prostate cancer * Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Urinary Incontinence | Twelve Months Post-operative | to determine if patients who undergo early apical release HoLEP have reduced rates of post-operative urinary incontinence compared to classic HoLEP as measured by patient report of leakage |
Countries
United States
Outcome results
None listed