HoLEP Sexual Survivorship

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lower Urinary Tract Symptoms; BPH
• Intervention / Treatment: Other: Telephone Interview; Other: Questionnaires over the span of 24 months

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 252

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males 18-100 years old with decision making capability electing to pursue HoLEP for the treatment of bothersome lower urinary tract symptoms.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Focus Group; To better assess what questions are pertinent to patient sexual satisfaction post-HoLEP, the study team will first conduct a preliminary study of 15 patients who are currently sexually active after the HoLEP procedure. The preliminary study will be conducted by a one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP.	Other: Telephone Interview; A one-time 30-45-minute telephone interview and discussion regarding the participants' after HoLEP experience and sexual satisfaction following HoLEP.
Longitudinal Cohort; The main longitudinal study in which the study team will follow HoLEP patients for 24 months post-operatively. The longtiudinal study cohort is powered to detect a clinically meaningful discrepancy in symptoms after the HoLEP procedure and patient reported ratings.	Other: Questionnaires over the span of 24 months; Participants will complete questionnaires at 1, 3, 6, 12, and 24 months post-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejaculatory function	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
Ejaculatory bother	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile function	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 years
Sexual function	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.	2 years
Sexual function and sexual satisfaction	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).	2 years

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Sexual satisfaction; Men's sexual health
• Additional Relevant MeSH Terms: Urological Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Sexual Behavior; Lower Urinary Tract Symptoms; Orgasm; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: STU00226001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No