Ejaculatory-Sparing HoLEP vs Standard HoLEP

NCT07631286 | Recruiting

• 1 other identifier: STU00225807
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Enlarged Prostate With Lower Urinary Tract Symptoms; Enlarged Prostate (BPH)

Keywords

HoLEP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Sexual satisfaction

  1 year

• Urinary satisfaction

  1 year

• Urinary satisfaction

  1 year

Study Arms (2)

Standard HoLEP

NO INTERVENTION

HoLEP procedure performed using standard care technique.

ES-HoLEP

ACTIVE COMPARATOR

HoLEP procedure performed using ejaculatory-sparing HoLEP technique.

Other: Ejaculatory-sparing (ES-sparing) HoLEP

Interventions

Ejaculatory-sparing (ES-sparing) HoLEP OTHER

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.

ES-HoLEP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy E Krambeck, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa McDonald, MPH

CONTACT

312-695-8146; alyssa.mcdonald@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Endourology/Stone Division

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)