What this study is
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.
What's being tested
- Holmium Laser Enucleation of Prostate (HoLEP)
Intervention · PROCEDURE
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.
Study details
- Sponsor
- University of Kansas Medical Center
- Conditions
- Prostate Cancer · Lower Urinary Tract Symptoms
- Enrolling
- 30 people
- Starts
- 2019-09-19
- Est. completion
- 2035-01
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kansas Health System
Kansas City, Kansas, United States
Recruiting
Study team
Sponsor
University of Kansas Medical Center
Study ID 143226
Principal investigator
Bristol Whiles, MD
University of Kansas Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.