IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostatic Median Lobe for the Treatment of Benign Prostatic Hyperplasia in Men With Prominent Median Lobe Desiring Preservation of Ejaculation

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.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males 45 years of age or older who opt for surgical management of their BPH with desire for preservation of ejaculatory function.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Simultaneous UroLift™ and HoLEP; UroLift System	Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 12 months
Post-Operative measurement of Peak Urine Flow Rate (Qmax)	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.	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Donald Neff, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): January 14, 2025
• Study Completion (Actual): January 14, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: BPH
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: HSC 149327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No