NCT03768765

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Holmium Laser Prostate Surgery	Patients will undergo standard of care holmium laser prostate surgery

Timeline

• Start date: 2018-11-15
• Primary completion: 2024-06-19
• Completion: 2024-08-27
• First posted: 2018-12-07
• Last updated: 2024-10-02

Locations

1 site across 1 country: United States