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.
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.
Study Type
OBSERVATIONAL
Enrollment
3
Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostate (HoLEP) for the Treatment of BPH in Men with Prominent Median Lobe Desiring Preservation of Ejaculation
University of Kansas Medical Center
Kansas City, Kansas, United States
International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
To evaluate improvement of symptoms through the International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months. The IPSS is an 8-question screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Scoring: 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Time frame: Up to 12 months
Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).
Evaluate post-operative participant reported outcomes using Benign Prostatic Hyperplasia Impact Index (BPHII). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Time frame: Up to 12 months
Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).
Evaluate post-operative sexual function using participant reported outcome International Index of Erectile Function (IIEF). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Time frame: Up to 12 months
Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).
Evaluate post-operative sexual function using participant reported outcome Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Time frame: Up to 12 months
Post-Operative measurement of Peak Urine Flow Rate (Qmax)
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Evaluate post-operative lower urinary tract symptoms further with Peak Urine Flow Rate (Qmax). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Time frame: Up to 12 months
Post-Operative measurement of Post Void Residual (PVR)
Evaluate post-operative lower urinary tract symptoms further with Post Void Residual (PVR). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority.
Time frame: Up to 12 months