Benign Prostatic HyperplasiaNCT02019030
Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode
An observational study of Benign Prostatic Hyperplasia, run by Olympus Corporation of the Americas at 2 sites in United States.
Trial summary
The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation medication. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to 3 Jan 2017
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic BPH patients seen at Urology clinic at Loma Linda University Medical Center and VA Greater Los Angeles Healthcare System
Who may be able to join
- Men with obstructive symptoms due to benign prostatic hyperplasia who are also on anticoagulant regimen.
- Anticoagulant regiments include: Aspirin 81mg, Aspirin 325mg, Adenosine diphosphate (ADP) receptor inhibitors, Cilostazol, Dabigatran, Dipyridamole, or Warfarin. The patient will be stable on their dosage regimen for at least 3 months.
- Maximum flow rate <15ml/s by uroflowmetry.
- International Prostate Symptom Score (IPSS)≥10.
Who cannot join
- Patients with coagulopathy, INR exceeding 3.
- Anti-coagulation dose changes within 3 months of surgery.
- Patients not medically cleared to undergo surgery for medical reasons.
- Patients with neurogenic bladder (bladder affected due to a neurologic cause).
- Urethral stricture, obstruction due to stricture.
- Suspected bladder or prostate cancer.
- Prostate size greater than 80 cc.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University Medical Center Urology Department
Loma Linda, California, 92354
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
Official title: Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode - An Observational Study
The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation medication.
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, Transurethral vaporization of prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BPH on anticoagulation | Patients with Benign Prostatic Hyperplasia (BPH) undergoing Transurethral Vaporization of Prostate and are on anticoagulant medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants
Measured: Introperative
Secondary outcomes (3)
Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire
Measured: Before surgery and 1, 3, 6 month follow up visits
Assessment of subjective patient improvement on the Sexual Health Inventory for Men (SHIM) score
Measured: Before surgery and 1, 3, 6 month follow-up
Measurement of maximum urine flow rate as measured by urine flowmetry
Measured: Before surgery and 1, 3, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
Why it stopped: Not meeting enrollment goals
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loma Linda University, VA Greater Los Angeles Healthcare System
- Responsible party
- Sponsor
- Investigators
- Edmund Ko, MD, Principal investigator, Loma Linda University Medical CenterCarol J Bennett, MD, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019030
- Sponsor's protocol ID
- 5130322
- Status last verified
- Apr 2018
- First submitted
- 11 Dec 2013
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode - An Observational Study
- ClinicalTrials.gov ID
- NCT02019030
- Acronym / sponsor ID
- 5130322
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, Transurethral vaporization of prostate
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not meeting enrollment goals
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Collaborators
- Loma Linda University, VA Greater Los Angeles Healthcare System
- Study start
- Dec 2013 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 24 Dec 2013 (estimated)
- 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.
The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation medication.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPH on anticoagulation | – | –Patients with Benign Prostatic Hyperplasia (BPH) undergoing Transurethral Vaporization of Prostate and are on anticoagulant medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic BPH patients seen at Urology clinic at Loma Linda University Medical Center and VA Greater Los Angeles Healthcare System
Key inclusion criteria (4 listed)
- Men with obstructive symptoms due to benign prostatic hyperplasia who are also on anticoagulant regimen.
- Anticoagulant regiments include: Aspirin 81mg, Aspirin 325mg, Adenosine diphosphate (ADP) receptor inhibitors, Cilostazol, Dabigatran, Dipyridamole, or Warfarin. The patient will be stable on their dosage regimen for at least 3 months.
- Maximum flow rate <15ml/s by uroflowmetry.
- International Prostate Symptom Score (IPSS)≥10.
Key exclusion criteria (7 listed)
- Patients with coagulopathy, INR exceeding 3.
- Anti-coagulation dose changes within 3 months of surgery.
- Patients not medically cleared to undergo surgery for medical reasons.
- Patients with neurogenic bladder (bladder affected due to a neurologic cause).
- Urethral stricture, obstruction due to stricture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants
Time frame: Introperative
3 secondary outcomes
Assessment of subjective patient improvement on the International Prostate Symptom Score questionnaire
Time frame: Before surgery and 1, 3, 6 month follow up visits
Assessment of subjective patient improvement on the Sexual Health Inventory for Men (SHIM) score
Time frame: Before surgery and 1, 3, 6 month follow-up
Measurement of maximum urine flow rate as measured by urine flowmetry
Time frame: Before surgery and 1, 3, 6 month follow-up
Results and safety
The study was stopped early (reason given: Not meeting enrollment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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.
Edmund Ko, MD principal investigator
Loma Linda University Medical Center
Carol J Bennett, MD principal investigator
VA Greater Los Angeles Healthcare System
2 sites 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 Olympus Corporation of the Americas at 2 sites 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 4 inclusion and 7 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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Not meeting enrollment goals). 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?
Complication rates when the PlasmaButton Electrode is used to perform TUVP (Transurethral Vaporization of the Prostate) on patients on anticoagulants (time frame: Introperative). 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 4 Apr 2018.