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

NCT03768765 | Terminated

• 1 other identifier: 143049
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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).

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Bladder Function

  The primary objective is to determine if patients who undergo holmium laser surgery prior to being placed on long term medication for benign prostatic hyperplasia (BPH) have a greater improvement in their bladder function, as measured by urodynamics, when compared to patients who undergo holmium laser surgery after being placed on long term medication for BPH.

  Six Months

Secondary Outcomes (3)

• Improvement in Quality of Life

  Six Months

• Complete Emptying

  Six Months

• Lower Urinary Tract Symptoms

  Six Months

Study Arms (2)

Long Term Medication Usage

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

Procedure: Holmium Laser Prostate Surgery

Short Term Medication Usage

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

Procedure: Holmium Laser Prostate Surgery

Interventions

Holmium Laser Prostate Surgery PROCEDURE

Patients will undergo standard of care holmium laser prostate surgery

Long Term Medication Usage; Short Term Medication Usage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will present to clinic for treatment of BPH

You may qualify if:

• Patients must be 18 years of age or older
• Patients must present to clinic with a diagnosis of benign prostatic hyperplasia with lower urinary tract symptoms
• Patients must be scheduled to undergo a holmium laser prostate surgery (enucleation or ablation)

You may not qualify if:

• Patients who are under 18 years of age are not eligible.
• Patients who have a diagnosis of bladder cancer are not eligible.
• Patient who have a diagnosis of prostate cancer are not eligible.
• Patients with an elevated prostate-specific antigen (PSA) suggesting prostate cancer are not eligible unless patient has prior negative prostate biopsy.
• Patients who have acute prostatitis, a prostate abscess, or neurogenic bladder are not eligible

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 7, 2018
• Study Start: November 15, 2018
• Primary Completion: June 19, 2024
• Study Completion: August 27, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)