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NCT Number: NCT07631286

Ejaculatory-Sparing HoLEP vs Standard HoLEP

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

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Key information

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Amy E Krambeck, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of retrograde ejaculation

    Time frame: 1 year

    Patient reported incidence of experiencing retrograde ejaculation

  2. Ejaculatory satisfaction

    Time frame: 1 year

    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.

Secondary outcomes

  1. Sexual satisfaction

    Time frame: 1 year

    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.

  2. Urinary satisfaction

    Time frame: 1 year

    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

  3. Urinary satisfaction

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa McDonald, MPH

CONTACT

[email protected]

312-695-8146

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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