Ejaculatory-Sparing HoLEP vs Standard HoLEP

Ejaculatory-sparing Holmium Laser Enucleation of the Prostate (HoLEP) vs Standard HoLEP: a Randomized Controlled Trial

The objective of this study is to compare a new surgical technique for HoLEP that will allow for sparing of ejaculation post-HoLEP.

Study Overview

• Status: Recruiting
• Conditions: Enlarged Prostate (BPH); Enlarged Prostate With Lower Urinary Tract Symptoms
• Intervention / Treatment: Other: Ejaculatory-sparing (ES-sparing) HoLEP

Detailed Description

In this study, we aim to assess the efficacy of ejaculatory-sparing HoLEP (ES-HoLEP) in preserving ejaculation while also maintaining good urinary outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alyssa McDonald, MPH; Phone Number: 312-695-8146; Email: alyssa.mcdonald@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Principal Investigator: Amy E Krambeck, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Patients who are sexually active with antegrade ejaculation who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms.

Exclusion Criteria:

• Patients with pre-existing retrograde ejaculation
• Patients who are not sexually active
• Patients with indwelling urinary catheter prior to surgery, neurological disease, or history of prior prostatic/urethral surgery that may impact ejaculation
• Patients who lack decisional capacity
• Patients unable to read/speak English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard HoLEP; HoLEP procedure performed using standard care technique.
Active Comparator: ES-HoLEP; HoLEP procedure performed using ejaculatory-sparing HoLEP technique.	Other: Ejaculatory-sparing (ES-sparing) HoLEP; The ejaculatory sparing technique involves sparing the distal apex of the prostate in particular the anterior portion of the prostate which will allow for coaptation necessary for antegrade ejaculation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of retrograde ejaculation	Patient reported incidence of experiencing retrograde ejaculation	1 year
Ejaculatory satisfaction	Patient reported satisfaction of ejaculation using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5). Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual satisfaction	Patient reported sexual satisfaction using the Sexual Health Inventory for Men (SHIM) questionnaire. The Sexual Health Inventory for Men (SHIM) contains 5 questions that is individually scored on a scale of 0 to 5. The SHIM score is calculated by adding up the scores of the 5 individual questions. Interpretation: Higher scores indicate better erectile function, while lower scores denote erectile dysfunction. A total score of 21 or less indicates that erectile dysfunction is present and should be addressed with a healthcare provider.	1 year
Urinary satisfaction	Patient reported urinary satisfaction using the International Prostate Symptom Score (IPSS) questionnaire. The International Prostate Symptom Score (IPSS) is calculated by asking patients to rate 7 urinary symptoms over the past month on a scale from 0 to 5. These scores are simply added together to yield a total symptom severity score ranging from 0 to 35. An 8th question measures overall Quality of Life (QoL) but is not factored into the numerical total. Interpretation: the total score range is from 0 to 35. The total score indicates symptom severity: 0-7: Mildly symptomatic 8-19: Moderately symptomatic 20-35: Severely symptomatic	1 year
Urinary satisfaction	Patient reported urinary satisfaction using the Michigan Incontinence Symptom Index (M-ISI) questionnaires. The M-ISI (Michigan Incontinence Symptom Index) questionnaire is a 10-item clinical tool used to evaluate the severity of urinary incontinence and how much it bothers the patient. It is calculated by assigning scores (0 to 4) to each answer and summing them across two primary domains. Total M-ISI Severity Domain (Items 1-8): Sum of the scores for the first 8 questions. This evaluates incontinence subdomains (Stress Urinary Incontinence, Urgency Urinary Incontinence, and Pad Use). Possible score range 0 to 32. Bother Domain (Items 9-10): Sum of the scores for questions 9 and 10. This measures the emotional and physical impact of the leakage. Possible score range 0 to 8. Interpretation: Higher scores indicate the individual is likely incontinent or has experience with incontinence.	1 year

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Amy E Krambeck, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HoLEP
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: STU00225807

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