Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)

Benign Prostate Hyperplasia Clinical Trial

Official title:

Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02021032
• Other study ID #: 101-04-401-01
• Status: Recruiting
• Phase: Phase 4
• First received: December 16, 2013
• Last updated: September 23, 2015
• Start date: February 2006
• Est. completion date: August 2018

Study information

• Verified date: September 2015
• Source: Medifocus, Inc.
• Contact: Varada Bidargaddi
• Email: varada.bidargaddi[@]kentron.co
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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").

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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:

1. 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.

2. 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.

3. 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Prolieve
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.

Locations

Country	Name	City	State
United States	Albany Medical College Division of Urology	Alabany	New York
United States	Merrimack Urology Associates PC	Chelmsford	Massachusetts
United States	Mobley Research Center	Houston	Texas
United States	Midtown Urologic Trials, PC	New York	New York
United States	Winter Park Urology	Orlando	Florida
United States	Winter Park Urology	Orlando	Florida
United States	North Fulton Urology	Roswell	Georgia
United States	Regional Urology	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Medifocus, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years	No
Secondary	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.	5 years	No