HoLEP Sexual Survivorship

NCT07660068 | Enrolling By Invitation

• 1 other identifier: STU00226001
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BPH; Lower Urinary Tract Symptoms

Keywords

Sexual satisfaction; Men's sexual health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Erectile function

  2 years

• Sexual function

  2 years

• Sexual function and sexual satisfaction

  2 years

Study Arms (2)

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

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

Interventions

Telephone Interview OTHER

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

Focus Group

Questionnaires over the span of 24 months OTHER

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

Longitudinal Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Orgasm

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endourology and Stone Disease in the Department of Urology, Edmund Andrews Professor of Urology

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)