Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes (HoLEP EAR)

University of Kansas

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: EAR HoLEP; Procedure: Classic HoLEP

Study type: Interventional

Funder types: Other

Identifiers

NCT04566588

145490

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Early apical release holmium enucleation of the prostate

Experimental group

Description:

Early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia

Treatment:

Procedure: EAR HoLEP

Classic holmium enucleation of the prostate

Active Comparator group

Description:

Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia

Treatment:

Procedure: Classic HoLEP