Patient Perspectives on the Trade-off Between Voiding Improvement and Sexual Dysfunction Following HoLEP
| Registry | NCT07660068 |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 252 (Estimated) |
| Sponsor | Northwestern University (Other) |
| Conditions | BPH, Lower Urinary Tract Symptoms |
| Interventions | Telephone Interview, Questionnaires over the span of 24 months (Other) |
| Dates | start 2026-05-26, primary completion 2027-06-01 (estimated), completion 2029-06-01 (estimated), first posted 2026-06-22, last updated 2026-10-15 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Focus Group | Other: Telephone Interview | 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. | |
| Longitudinal Cohort | Other: Questionnaires over the span of 24 months | 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. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Northwestern University | Chicago, Illinois | United States |