IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

Recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)

• Registration Number: NCT06157164
• Lead Sponsor: University of Kansas Medical Center

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.

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 Timeline

• Study Start: 2023-02-06
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-05
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-02-06
• Study Completion: 2025-02-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simultaneous UroLift™ and HoLEP	UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)	UroLift System

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.	Up to 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

Secondary Outcome Measures

Name	Time	Method
Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).	Up to 12 months	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.
Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).	Up to 12 months	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.
Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).	Up to 12 months	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.
Post-Operative measurement of Peak Urine Flow Rate (Qmax)	Up to 12 months	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.
Post-Operative measurement of Post Void Residual (PVR)	Up to 12 months	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States