Clinical trial NCT06157164: IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 3
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
timeFrame: Up to 12 months
Secondary outcomes:
measure: Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).
timeFrame: Up to 12 months
measure: Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).
timeFrame: Up to 12 months
measure: Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).
timeFrame: Up to 12 months
measure: Post-Operative measurement of Peak Urine Flow Rate (Qmax)
timeFrame: Up to 12 months
measure: Post-Operative measurement of Post Void Residual (PVR)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Donald Neff
role: PRINCIPAL_INVESTIGATOR
References: