Recruiting

HoLEP

Sponsor:

University of Kansas Medical Center

Code:

NCT03802851

Conditions

Prostate Cancer

Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Holmium Laser Enucleation of Prostate (HoLEP)

Study Details

Brief summary:

To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.

Conditions

Prostate Cancer

Lower Urinary Tract Symptoms

Study ID

NCT03802851

Start date

Sep 19, 2019

Status verified date

Jul, 2026

Completion date

Jan, 2035

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as defined by a post-void residual of greater than or equal to 350mL and/or as defined by catheter dependence
  • Patients must be diagnosed with prostate cancer by pathological tissue analysis
  • Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer

Exclusion Criteria:

  • Patients who are under 18 years of age are not eligible
  • Patients who have a diagnosis of bladder cancer are not eligible.
  • Patients with prior treatment for prostate cancer are not eligible.
  • Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible.
  • Patients with known metastatic prostate cancer are ineligible
  • Patients who are enrolled in other surgical or international trials at the time of this study are not eligible

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Holmium Laser Enucleation of Prostate (HoLEP)

Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.

no intervention: Control Arm

Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.

Interventions

Holmium Laser Enucleation of Prostate (HoLEP)

Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment use for men with bothersome lower urinary tract symptoms (LUTS) to improve their LUTS. During the procedure a thin telescope-like instrument is inserted into the urethra. The high-powered laser is then inserted through this instrument and used to carefully remove the excess prostate tissue that is causing obstruction of the urethra and contributing to the patient's lower urinary tract symptoms.

Primary outcome measure

  • Improvement in Quality of Life - One Year Post Operatively [ Time Frame: Quality of life will be assessed one year post-operatively ]
  • Improvement in Quality of Life - Five Years Post Operatively [ Time Frame: Quality of life will be assessed five years post-operatively ]

Central Contacts and Locations

Central contacts

Jane Ledesma, BS

(913) 588-8721jledesma2@kumc.edu

Locations

University of Kansas Health System

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-07-13.