BPHPhase 4NCT00199550
Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
A Phase 4 study testing Bipolar Transurethral Resection of the Prostate and Monopolar Transurethral Resection of the Prostate in people with BPH and Benign Prostatic Hyperplasia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in Canada.
Trial summary
This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- BPH, Benign Prostatic Hyperplasia
- What is being tested?
- Bipolar Transurethral Resection of the Prostate and Monopolar Transurethral Resection of the Prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesCanada
- Study dates
- May 2004to Jun 2008
- Phase
- Phase 4
- 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 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic benign prostatic hyperplasia including patients with acute urinary retention;
- Peak urinary flow rate < 12 ml/sec;
- American Urological Association (AUA) symptom score > 12.
Who cannot join
- Previous open or transurethral prostatic surgery;
- History of urethral stricture;
- Failure to discontinue alpha-adrenergic blocking agents for at least 14 days prior to surgery;
- Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior to surgery;
- Patient interested in future fertility;
- Patient with known neurogenic bladder dysfunction;
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- Untreated urinary tract infection;
- American Society of Anesthesiologist (ASA) Class >III;
- Patients requiring anticoagulation with Coumadin or Heparin;
- Patient unable or unwilling to comply with follow-up schedule.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Alberta Urology Institute Research Centre
Edmonton, Alberta, T5H 4B9
Hamilton District Urology Associaton
Hamilton, Ontario, L8N 1T8
Centre for Advanced Urological Research at Queen's University
Kingston, Ontario, K7L 3J7
Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, N6A 4V2
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
Can-Med Clinical Research Inc
Victoria, British Columbia, V8R 6T9
About this study
Official title: A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.
Read the detailed description
The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a < 24 hour post-operative hospital stay in > 50% of patients undergoing this procedure.
- Conditions
- BPH, Benign Prostatic Hyperplasia
- Being tested
- Bipolar Transurethral Resection of the Prostate, Monopolar Transurethral Resection of the Prostate
- Keywords
- Transurethral Resection of Prostate, TURP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar Transurethral Resection of the ProstateProcedure or surgery
Also called Vista, Bipolar TURP
Bipolar TURP
Monopolar Transurethral Resection of the ProstateProcedure or surgery
Also called Monopolar TURP
Monopolar TURP
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Bipolar Electrosurgical Unit Receives: Procedure: Bipolar Transurethral Resection of the Prostate |
| 1 | Active comparator | Monopolar Electrosurgical Unit Receives: Procedure: Monopolar Transurethral Resection of the Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.
Measured: 6 months
Secondary outcomes (1)
Pre and post-operative objective and subjective data for each treatment group will be assessed to determine safety and efficacy. Complications related to the surgical procedure will be noted by flexible cystoscopy at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Gyrus ACMI, Inc.
- Investigators
- Hassan Razvi, MD, FRCSC, Principal investigator, Urology, St. Joseph's Hospital, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199550
- Sponsor's protocol ID
- R-04-533
- Status last verified
- Jul 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
- ClinicalTrials.gov ID
- NCT00199550
- Acronym / sponsor ID
- R-04-533
- Conditions
- BPH, Benign Prostatic Hyperplasia
- Keywords
- Transurethral Resection of Prostate, TURP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Gyrus ACMI, Inc.
- Study start
- May 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Sep 2005 (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.
This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.
Detailed description
The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a < 24 hour post-operative hospital stay in > 50% of patients undergoing this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: Bipolar Transurethral Resection of the ProstateBipolar Electrosurgical Unit |
| 1 | Active comparator | Procedure: Monopolar Transurethral Resection of the ProstateMonopolar Electrosurgical Unit |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic benign prostatic hyperplasia including patients with acute urinary retention;
- Peak urinary flow rate < 12 ml/sec;
- American Urological Association (AUA) symptom score > 12.
Key exclusion criteria (10 listed)
- Previous open or transurethral prostatic surgery;
- History of urethral stricture;
- Failure to discontinue alpha-adrenergic blocking agents for at least 14 days prior to surgery;
- Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior to surgery;
- Patient interested in future fertility;
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 |
|---|---|---|
| Bipolar Transurethral Resection of the ProstateAlso: Vista, Bipolar TURPBipolar TURP | Procedure or surgery | 2 |
| Monopolar Transurethral Resection of the ProstateAlso: Monopolar TURPMonopolar TURP | Procedure or surgery | 1 |
Primary outcome
Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.
Time frame: 6 months
1 secondary outcome
Pre and post-operative objective and subjective data for each treatment group will be assessed to determine safety and efficacy. Complications related to the surgical procedure will be noted by flexible cystoscopy at 6 months.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
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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.
Hassan Razvi, MD, FRCSC principal investigator
Urology, St. Joseph's Hospital, University of Western Ontario
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bipolar Transurethral Resection of the Prostate and Monopolar Transurethral Resection of the Prostate in people with BPH and Benign Prostatic Hyperplasia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in Canada.
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 10 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: finished, as of the sponsor's last update on 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores. (time frame: 6 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 29 Jul 2008.