Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)

Experience from clinic has suggested that men who receive medication for long periods of
time, defined as over a year for study purposes, have a poorer response to surgical treatment
for benign prostatic hyperplasia (BPH). It has previously been demonstrated that medication
use does not alter the perioperative outcomes after HoLEP; however, to our knowledge, no
study to date has investigated holmium laser prostate surgery outcomes associated with the
duration of pre-operative medication therapy.

Some of the more common medications for BPH are alpha-1 blockers and 5-alpha-reductase
inhibitors. A five-year study of patients showed that treatment failure, defined as need for
surgery or conversion to other medication, was observed in 18.8% of patients who were
prescribed tamsulosin, an alpha-1 blocker, for BPH. The study further suggested that
treatment with this class of medication may not be appropriate long-term for those patients
with a large prostate volume and/or a large post-void residual volume. Similar results have
been demonstrated with 5-alpha-reductase inhibitors, with more than 30% of men not responding
to its therapeutic effects.

The progression of BPH symptoms is complex and the result of multiple pathways such as
androgen receptor signaling, proinflammatory cytokines, and growth factor signals, all of
which can be affected by medication. 5-alpha-reductase inhibitors work by limiting the
conversion of testosterone to dihydrotestosterone. An overabundance of dihydrotestosterone
can affect the regulation of cell cycle, cell growth, and differentiation in the prostate,
leading to BPH. Alpha-1 blockers work by mediating prostate smooth-muscle relaxation though
it is unclear if this specific action is the reason for the relief of BPH symptoms.
Considering the aforementioned pathways, the goal of this clinical trial is to investigate if
a prolonged period of medication is associated with the effectiveness of holmium laser
surgery. By grouping patients based on medication treatment time, the goal is to determine if
their responses are different and clinically significant, in order to better inform standard
of care practices for those with BPH.

Inclusion Criteria:

1. Patients must be 18 years of age or older

2. Patients must present to clinic with a diagnosis of benign prostatic hyperplasia with
lower urinary tract symptoms

3. Patients must be scheduled to undergo a holmium laser prostate surgery (enucleation or
ablation)

Exclusion Criteria:

1. Patients who are under 18 years of age are not eligible.

2. Patients who have a diagnosis of bladder cancer are not eligible.

3. Patient who have a diagnosis of prostate cancer are not eligible.

4. Patients with an elevated prostate-specific antigen (PSA) suggesting prostate cancer
are not eligible unless patient has prior negative prostate biopsy.

5. Patients who have acute prostatitis, a prostate abscess, or neurogenic bladder are not
eligible