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Recruiting NCT07631286

Ejaculatory-Sparing HoLEP vs Standard HoLEP

No phase Interventional Enlarged Prostate (BPH) Enlarged Prostate With Lower Urinary Tract Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ejaculatory-sparing (ES-sparing) HoLEP.
Who it may be relevant to
Registry conditions: Enlarged Prostate (BPH), Enlarged Prostate With Lower Urinary Tract Symptoms. Basic parameters: 18 years — 100 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ejaculatory-sparing Holmium Laser Enucleation of the Prostate (HoLEP) vs Standard HoLEP: a Randomized Controlled Trial

Overview

The objective of this study is to compare a new surgical technique for HoLEP that will allow for sparing of ejaculation post-HoLEP.

Detailed description

The primary aim of this study is to assess the efficacy of ejaculatory-sparing HoLEP (ES-HoLEP) in preserving ejaculation while also maintaining good urinary outcomes.

Interventions

  • Other Ejaculatory-sparing (ES-sparing) HoLEP
    The ejaculatory sparing technique involves sparing the distal apex of the prostate in particular the anterior portion of the prostate which will allow for coaptation necessary for antegrade ejaculation.

Primary outcome measures

  • Incidence of retrograde ejaculation [Time frame: 1 year]
  • Ejaculatory satisfaction [Time frame: 1 year]
Secondary outcome measures (3)
  • Sexual satisfaction [Time frame: 1 year]
  • Urinary satisfaction [Time frame: 1 year]
  • Urinary satisfaction [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

\- Patients who are sexually active with antegrade ejaculation who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms.

Exclusion criteria

  • Patients with pre-existing retrograde ejaculation
  • Patients who are not sexually active
  • Patients with indwelling urinary catheter prior to surgery, neurological disease, or history of prior prostatic/urethral surgery that may impact ejaculation
  • Patients who lack decisional capacity
  • Patients unable to read/speak English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT07631286 · STU00225807

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗