IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-06

Study Completion Date

2025-01-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Simultaneous UroLift™ and HoLEP

UroLift System

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

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No