Benign Prostate HyperplasiaPhase 4NCT02021032
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
A Phase 4 study testing Prolieve in people with Benign Prostate Hyperplasia, run by Medifocus, Inc. at 8 sites in United States.
Trial summary
The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- Prolieve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2006to Aug 2018
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with symptomatic BPH.
- Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
- AUA symptom score value ≥9(9).
- Signed informed consent.
Who cannot join
- Subjects whose pain response has been significantly decreased by any means (because the subject's ability to detect pain is a treatment safety mechanism).
- Subject with a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
- Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject.
- Subject with the confirmed or suspected malignancy of the prostate
- Subject with the confirmed or suspected bladder cancer
- PSA >10 ng/mL
Show all 25Show fewer
- Subject with previous treatment to the prostate (e.g., surgery, balloon dilation, stents, laser, TUNA, or Indigo prostatectomy) and/or non-metallic urogenital implants (e.g., penile prostheses, artificial urinary sphincters)
- Subject with prostate weighing <20 or >80g.
- Subject with previous pelvic irradiation or radial pelvic surgery
- Subject having large, obstructive middle lobe
- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
- Subject with urethral stricture and/or bladder stones
- Active urinary tract infection.
- Subject with neurogenic bladder and/or sphincter abnormalities due to Parkinson's, multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease process.
- Residual bladder volume >250 mL measured by ultrasound.
- Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
- Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
- Concomitant medicating of the following:
- Bladder antispasmodics (Ditropan or Detrol) within one week of treatment, unless there is documented evidence that the subject has been on the same drug dose for at least three months with a stable voiding pattern. The drug dose will not be altered or discontinued for the entrance into or throughout the study.
- 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.
- Alpha blockers, antidepressants, androgens, within one week of treatment.
- Subject interested in future fertility/fathering children.
- Subject with full urinary retention.
- Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
- Subject with prostatic urethra length of <1.2 cm or >5.5 cm.
Trial locations and contacts
8 sites in 1 country.
Varada Bidargaddi contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Albany Medical College Division of Urology
Alabany, New York
Brenda Romeo, 518-262-8579, ccpurologyresearch@communitycare.com
Ronald Kaufman, MD
- Recruiting
Merrimack Urology Associates PC
Chelmsford, Massachusetts
Nancy Leahy, MD, 978-256-9507, nleahymu@yahoo.com
Robert Edelstein, MD
- Recruiting
Mobley Research Center
Houston, Texas
Minna Tambourides, 832-522-8312, mtambourides@tmhs.org
David Mobley, MD
- Recruiting
Midtown Urologic Trials, PC
New York, New York
Carini Perello, 212-686-1140, carinialmanzar@yahoo.com
Robert Salant, MD
- Recruiting
Winter Park Urology
Orlando, Florida
Felipe Valerio, 407-992-3170, felipevalerio@wpuafl.com
David Jablonski, MD
- Recruiting
Winter Park Urology
Orlando, Florida
Lesbia Candelaria, 407-422-2728, lesbiavazquez@wpuafl.com
Gary Kalser, MD
- Recruiting
North Fulton Urology
Roswell, Georgia
Elizabeth Wilson, 770-752-8632, ewilson@nfurology.com
Lewis Kriteman, MD
- Recruiting
Regional Urology
Shreveport, Louisiana
Tracey Robinson, 318-683-0411 ext. 173, trobinson@regionalurology.com
Ralph Henderson, MD
About this study
The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Prolieve
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlieveDevice
Prolieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression.
| Study group | Role | What they receive |
|---|---|---|
| Prolieve | Experimental | Prolieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression. Receives: Device: Prolieve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Re-Treatment
Time to re-treatment will be estimated using Kaplan Meier estimation techniques. The re-treatment rate at years 1 through 5 will be estimated and 95% confidence intervals obtained, and the median time to re-treatment will be estimated. Subjects who receive re-treatment will be classed as treatment failures. Subjects who are lost to follow-up will be considered as re-treated at their last known study visit. In addition, a missing at random (MAR) analysis will be performed.
Measured: 5 years
Secondary outcomes (1)
Change from Baseline in American Urological Association (AUA) Total Score at 5 years
Measured based on the number of subjects who worsened, had no change (1-29%), had a 30% or greater improvement or who are missing, based on the change in AUA total score compared to individual baseline for each follow-up evaluation. A responder analysis will also be done on peak flow rate (PFR) with the following categories: the number of subjects who worsened, had no change (1-19%), had a 20% or greater improvement or who are missing, based on the change in PFR compared to individual baseline for each follow-up evaluation.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startFeb 2006
- Primary completionFeb 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medifocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Perry Weiner, MD, Study director, Jefferson Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021032
- Sponsor's protocol ID
- 101-04-401-01
- Status last verified
- Sep 2015
- First submitted
- 16 Dec 2013
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Olweny EO, Jow SL, Jow WW. Prolieve Transurethral Thermodilatation for Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results from a Prospective Multicenter Trial. J Endourol. 2022 Jan;36(1):117-123. doi: 10.1089/end.2021.0240. Epub 2021 Nov 1.
PubMed 34314241
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT02021032
- Acronym / sponsor ID
- 101-04-401-01
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medifocus, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 27 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 primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolieve | Experimental | Device: ProlieveProlieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with symptomatic BPH.
- Peak Urine flow rate <12 ml/sec on voided volume of >125mL.
- AUA symptom score value ≥9(9).
- Signed informed consent.
Key exclusion criteria (25 listed)
- Subjects whose pain response has been significantly decreased by any means (because the subject's ability to detect pain is a treatment safety mechanism).
- Subject with a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
- Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject.
- Subject with the confirmed or suspected malignancy of the prostate
- Subject with the confirmed or suspected bladder cancer
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 |
|---|---|---|
| ProlieveProlieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression. | Device | Prolieve |
Primary outcome
Time to Re-Treatment
Time frame: 5 years
Time to re-treatment will be estimated using Kaplan Meier estimation techniques. The re-treatment rate at years 1 through 5 will be estimated and 95% confidence intervals obtained, and the median time to re-treatment will be estimated. Subjects who receive re-treatment will be classed as treatment failures. Subjects who are lost to follow-up will be considered as re-treated at their last known study visit. In addition, a missing at random (MAR) analysis will be performed.
1 secondary outcome
Change from Baseline in American Urological Association (AUA) Total Score at 5 years
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Derived from this study: PubMed 34314241Olweny EO, Jow SL, Jow WW. Prolieve Transurethral Thermodilatation for Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results from a Prospective Multicenter Trial. J Endourol. 2022 Jan;36(1):117-123. doi: 10.1089/end.2021.0240. Epub 2021 Nov 1.
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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.
Varada Bidargaddi contact
Perry Weiner, MD study director
Jefferson Urology
8 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 Prolieve in people with Benign Prostate Hyperplasia, run by Medifocus, Inc. at 8 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 25 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: status not confirmed, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Varada Bidargaddi (varada.bidargaddi@kentron.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Re-Treatment (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02021032, which also lists 1 linked publication.
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 24 Sep 2015.