IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

University of Kansas

Status

Terminated

Conditions

Benign Prostatic Hyperplasia

Treatments

Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)

Study type

Observational

Funder types

Other

Identifiers

NCT06157164

HSC 149327

Details and patient eligibility

About

To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe.

Full description

Preserving ejaculation is a significant factor that impacts patient's decisions regarding what proceeding with treatment of BPH symptoms. The UroLiftTM system provides a safe procedure that has proven preservation of ejaculatory function. However, it is contraindicated in patients with prominent median lobes. The combination with laser median lobe enucleation may provide the same improvement in symptoms and widen patient inclusion criteria to those desire preserved ejaculation that also have a prominent median lobe.

Enrollment

3 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must be 45 years of age or older
Patients must be diagnosed with benign prostatic hyperplasia
Patients must opt for surgical management of their BPH with desire for preservation of ejaculatory function
Prominent median lobe with at least grade I intravesical protrusion of median lobe visualized on pre-operative cystoscopy

Exclusion criteria

Patients with baseline erectile and ejaculatory dysfunction as determined by a baseline IIEF-5 score < 15
Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
Patients with prostate glands greater or equal to 100 grams
Patients with less than a grade I intravesical protrusion of median lobe on pre-operative cystoscopy
Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.