Benign Prostatic HyperplasiaNCT03768765
Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)
An observational study of Benign Prostatic Hyperplasia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Holmium Laser Prostate Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 27 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will present to clinic for treatment of BPH
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Health System
Kansas City, Kansas, 66160
About this study
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).
Read the 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
- Being tested
- Holmium Laser Prostate Surgery
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Laser Prostate SurgeryProcedure or surgery
Patients will undergo standard of care holmium laser prostate surgery
| Study group | Role | What they receive |
|---|---|---|
| Long Term Medication Usage | Patients who have been on medication for over a year for benign prostatic hyperplasia (BPH) Receives: Procedure: Holmium Laser Prostate Surgery | |
| Short Term Medication Usage | Patients who have been on medication for under a year for benign prostatic hyperplasia (BPH) Receives: Procedure: Holmium Laser Prostate Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six Months
Secondary outcomes (3)
Improvement in Quality of Life
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.
Measured: Six Months
Complete Emptying
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.
Measured: Six Months
Lower Urinary Tract Symptoms
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.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start15 Nov 2018
- Primary completion19 Jun 2024
- Study completion27 Aug 2024
Why it stopped: Slow recruitment of patients who have been on medication for under a year for benign prostatic hyperplasia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Neff, MD, FACS, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768765
- Sponsor's protocol ID
- 143049
- Status last verified
- Sep 2024
- First submitted
- 3 Dec 2018
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Medication Therapy and Outcomes After Holmium Laser Prostate Surgery for Patients With Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT03768765
- Acronym / sponsor ID
- 143049
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment of patients who have been on medication for under a year for benign prostatic hyperplasia
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Term Medication Usage | – | Procedure: Holmium Laser Prostate SurgeryPatients who have been on medication for over a year for benign prostatic hyperplasia (BPH) |
| Short Term Medication Usage | – | Procedure: Holmium Laser Prostate SurgeryPatients who have been on medication for under a year for benign prostatic hyperplasia (BPH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will present to clinic for treatment of BPH
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium Laser Prostate SurgeryPatients will undergo standard of care holmium laser prostate surgery | Procedure or surgery | Long Term Medication Usage, Short Term Medication Usage |
Primary outcome
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.
3 secondary outcomes
Improvement in Quality of Life
Time frame: Six Months
Complete Emptying
Time frame: Six Months
Lower Urinary Tract Symptoms
Time frame: Six Months
Results and safety
The study was stopped early (reason given: Slow recruitment of patients who have been on medication for under a year for benign prostatic hyperplasia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment of patients who have been on medication for under a year for benign prostatic hyperplasia). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Function (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.