HoLEP Sexual Survivorship

NCT07660068 — Enrolling by invitation, 252 participants, Northwestern University

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

RegistryNCT07660068
StatusEnrolling by invitation
Study typeObservational
Enrollment252 (Estimated)
SponsorNorthwestern University (Other)
ConditionsBPH, Lower Urinary Tract Symptoms
InterventionsTelephone Interview, Questionnaires over the span of 24 months (Other)
Datesstart 2026-05-26, primary completion 2027-06-01 (estimated), completion 2029-06-01 (estimated), first posted 2026-06-22, last updated 2026-10-15
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for BPH All trials for Lower Urinary Tract Symptoms All trials of Telephone Interview All trials of Questionnaires over the span of 24 months

-Summary

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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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Focus GroupOther: Telephone InterviewTo 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.
Longitudinal CohortOther: Questionnaires over the span of 24 monthsThe 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.
  • 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

+Outcome measures

Primary outcomes

  • Ejaculatory function [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.
  • Ejaculatory bother [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

  • Erectile function [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.
  • Sexual function [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.
  • Sexual function and sexual satisfaction [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).

+Eligibility

Sex: Male, ages: 18 Years to 100 Years

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

+Locations (1)

FacilityCityCountryStatus
Northwestern UniversityChicago, IllinoisUnited States