IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

NCT06157164 | Terminated

• 1 other identifier: HSC 149327
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).

  Up to 12 months

• Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).

  Up to 12 months

• Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).

  Up to 12 months

• Post-Operative measurement of Peak Urine Flow Rate (Qmax)

  Up to 12 months

• Post-Operative measurement of Post Void Residual (PVR)

  Up to 12 months

Study Arms (1)

Simultaneous UroLift™ and HoLEP

UroLift System

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

Interventions

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

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

Simultaneous UroLift™ and HoLEP

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Donald Neff

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: December 5, 2023
• Study Start: February 6, 2023
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)