Recruiting

HoLEP

Sponsor:

Northwestern University

Code:

NCT07631286

Conditions

Enlarged Prostate (BPH)

Enlarged Prostate With Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ejaculatory-sparing (ES-sparing) HoLEP

Study Details

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 (BPH)

Enlarged Prostate With Lower Urinary Tract Symptoms

Study ID

NCT07631286

Start date

Jun 15, 2026

Status verified date

Aug, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard HoLEP

HoLEP procedure performed using standard care technique.

active comparator: ES-HoLEP

HoLEP procedure performed using ejaculatory-sparing HoLEP technique.

Interventions

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.

Primary outcome measure

  • Incidence of retrograde ejaculation [ Time Frame: 1 year ]
  • Ejaculatory satisfaction [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Alyssa McDonald, MPH

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

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Amy E Krambeck, MD

More Information

Sponsor

Northwestern University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • HoLEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-20.