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

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ClinicalTrials.gov Identifier: NCT03768765
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Kerri Barnes, University of Kansas Medical Center

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).

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Procedure: Holmium Laser Prostate Surgery

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium

Group/Cohort Intervention/treatment
Long Term Medication Usage
Patients who have been on medication for over a year for benign prostatic hyperplasia (BPH)
Procedure: Holmium Laser Prostate Surgery
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)
Procedure: Holmium Laser Prostate Surgery
Patients will undergo standard of care holmium laser prostate surgery




Primary Outcome Measures :
  1. Bladder Function [ Time Frame: Six Months ]
    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.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Six Months ]
    The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia (BPH) have a greater improvement in their quality of life, as measured by questionnaires, when compared to patients who under holmium laser surgery after having received long term medication.

  2. Complete Emptying [ Time Frame: Six Months ]
    The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia have great improvement in complete emptying of their bladder, as measured by post void residual volume (PVR), when compared to patients who under holmium laser surgery after having received long term medication.

  3. Lower Urinary Tract Symptoms [ Time Frame: Six Months ]
    The secondary objectives are to determine if patients who undergo holmium laser surgery prior to long term medication for benign prostatic hyperplasia have great improvement in regards to their lower urinary tract symptoms, as measured by the American Urology Association (AUA) symptom score, when compared to patients who under holmium laser surgery after having received long term medication. The AUA symptom score is a measure of lower urinary tract symptoms and is scored on a scale of 0-25, with a score in the range of 0-8 indicating mild symptoms, 9-19 indicating moderate symptoms, and a score in 20-35 range indicating severe symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will present to clinic for treatment of BPH
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768765


Locations
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United States, Kansas
University of Kansas Health System Recruiting
Kansas City, Kansas, United States, 66160
Contact: Alexandra Dahlgren    913-574-0847    adahlgren@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center

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Responsible Party: Kerri Barnes, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03768765     History of Changes
Other Study ID Numbers: 143049
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male