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Enrolling by Invitation

NCT Number: NCT07660068

HoLEP Sexual Survivorship

The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).

In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function.

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Key information

Conditions

BPH Behavior Lower Urinary Tract Symptoms Orgasm Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms Urological Manifestations

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

The objective of this study is to evaluate how sexual function, ejaculatory function, and overall sexual satisfaction change following Holmium Laser Enucleation of the Prostate (HoLEP).

Retrograde ejaculation is a common and expected consequence of the procedure and meaningfully influences surgical decision-making. Through the study team's findings, the study team aims to characterize the longitudinal impact of HoLEP and if it induces patient regret.

In doing so, the study team will examine the trade-off between relief of lower urinary tract symptoms and changes in sexual function. This study seeks to generate patient-centered data to inform shared decision-making for men considering HoLEP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males 18-100 years old
  • Electing to undergo HoLEP for the treatment of bothersome lower urinary tract symptoms
  • Currently have present antegrade ejaculation (the standard, male ejaculatory process where semen is propelled forward and out through the urethra during orgasm).

Exclusion criteria

  • Patients with any of the following:
  • Indwelling urinary catheter prior to surgery
  • Neurological disease
  • History of prior prostatic/urethral surgery that may impact ejaculation
  • Patients who lack decisional capacity
  • Patients unable to read, understand, and speak English

Treatment and study plan

telephone interview

Other

A one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP.

Questionnaires over the span of 24 months

Other

Participants will complete questionnaires at 1, 3, 6, 12, and 24 months post-operatively

Primary outcomes

  1. Ejaculatory function

    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.

  2. Ejaculatory bother

    Time frame: 1 year

    Patient reported bothersome of ejaculation quality 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. Erectile function

    Time frame: 2 years

    Patient reported satisfaction of sexual function and overall sexual satisfaction using the International Index of Erectile Function-5 (IIEF-5).

    The IIEF (International Index of Erectile Function) is a 15-question, self-administered survey used globally as a clinical "gold standard" to diagnose the presence and severity of erectile dysfunction (ED) and track sexual health outcomes.

    Interpretation: The IIEF-5 exclusively assesses erectile and intercourse satisfaction, with scores ranging from 5 to 25. Higher scores generally indicate mild to no erectile dysfunction. Lower scores represent declining erectile function.

  2. Sexual function

    Time frame: 2 years

    Patient reported satisfaction of sexual function and overall sexual satisfaction using the SFI (Brief Sexual Function Inventory).

    The SFI is an 11-item, administered questionnaire used to evaluate male sexual function and how it is impacted by conditions like Lower Urinary Tract Symptoms (LUTS).

    Interpretation: Each of the 11 items is rated on a Likert scale (typically 0 to 4 points). The total score is the sum of the responses, with higher scores generally indicating better sexual function and lower scores highlighting more severe impairment or dysfunction.

  3. Sexual function and sexual satisfaction

    Time frame: 2 years

    Patient reported satisfaction of sexual function and overall sexual satisfaction using the MSF-4 (Male Sexual Function-4).

    The MSF-4 (Male Sexual Function-4) is a four-question survey designed to evaluate male sexual health in clinical urology settings. It is primarily used to track changes in sexual function for men dealing with Lower Urinary Tract Symptoms (LUTS) or Benign Prostatic Hyperplasia (BPH).

    Interpretation: Each of the 4 items uses a Likert-type scale (typically ranging from 1 to 4 or 1 to 5). Higher scores generally indicate better sexual functioning and higher satisfaction. Lower scores represent worsening sexual function or increased sexual dysfunction (such as erectile or ejaculatory issues).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Patient Perspectives on the Trade-off Between Voiding Improvement and Sexual Dysfunction Following HoLEP

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jun 22, 2026
Registry last updated
Jun 22, 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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