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

NCT ID: NCT03768765

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2024-08-27

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Long Term Medication Usage

Patients who have been on medication for over a year for benign prostatic hyperplasia (BPH)

Holmium Laser Prostate Surgery

Intervention Type: PROCEDURE

Patients will undergo standard of care holmium laser prostate surgery

Short Term Medication Usage

Patients who have been on medication for under a year for benign prostatic hyperplasia (BPH)

Holmium Laser Prostate Surgery

Intervention Type: PROCEDURE

Patients will undergo standard of care holmium laser prostate surgery

Interventions

Holmium Laser Prostate Surgery

Patients will undergo standard of care holmium laser prostate surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Don Neff, MD, FACS

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Kansas Health System

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

143049

Identifier Type: -

Identifier Source: org_study_id