Clinical trial NCT03768765: Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)
Official title: Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will present to clinic for treatment of BPH

Brief summary: To determine if the prior prolonged use of medication, as a treatment for benign prostatic hyperplasia, reduces the efficacy of Holmium laser enucleation of the prostate (HoLEP) for patients with benign prostatic hyperplasia (BPH).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bladder Function
timeFrame: Six Months
Secondary outcomes:
measure: Improvement in Quality of Life
timeFrame: Six Months
measure: Complete Emptying
timeFrame: Six Months
measure: Lower Urinary Tract Symptoms
timeFrame: Six Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
References: