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

NCT02021032 | Unknown Phase 4

• 1 other identifier: 101-04-401-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 8

Brief 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").

Conditions

Benign Prostate Hyperplasia

Keywords

BPH

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change from Baseline in American Urological Association (AUA) Total Score at 5 years

  5 years

Study Arms (1)

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.

Device: Prolieve

Interventions

Prolieve DEVICE

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.

Prolieve

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medifocus, Inc.: lead

Study Sites (8)

Winter Park Urology

Orlando, Florida, United States

RECRUITING

Winter Park Urology

Orlando, Florida, United States

RECRUITING

North Fulton Urology

Roswell, Georgia, United States

RECRUITING

Regional Urology

Shreveport, Louisiana, United States

RECRUITING

Merrimack Urology Associates PC

Chelmsford, Massachusetts, United States

RECRUITING

Albany Medical College Division of Urology

Alabany, New York, United States

RECRUITING

Midtown Urologic Trials, PC

New York, New York, United States

RECRUITING

Mobley Research Center

Houston, Texas, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34314241 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Perry Weiner, MD

  Jefferson Urology

  STUDY DIRECTOR

Central Study Contacts

Varada Bidargaddi

CONTACT

varada.bidargaddi@kentron.co

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 27, 2013
• Study Start: February 1, 2006
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (8)