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

Medifocus

Status and phase: Unknown; Phase 4

Conditions: Benign Prostate Hyperplasia

Treatments: Device: Prolieve

Study type: Interventional

Funder types: Industry

Identifiers

NCT02021032

101-04-401-01

Details and patient eligibility

About

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").

Enrollment: 250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

250 participants in 1 patient group

Prolieve

Experimental group

Description:

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.

Treatment:

Device: Prolieve