Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra: A Preliminary Investigatio
- Conditions
- Benign Prostatic Hyperplasia (BPH)Renal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12609000760279
- Lead Sponsor
- eoTract, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 70
Diagnosis of lateral lobe symptomatic BPH
- IPSS Symptom score >13
- Peak urine flow rate> than 5ml/sec but
<12ml/sec on a voided volume > 125 ml
- Prostate volume >20 grams to <100
grams
- American Society of Anesthesiologists
(ASA) risk group class I-III
- Normal microscopic urinalysis
- Stable prostate-specific antigen (PSA)
over two years, or agrees to undergo a
pre-treatment transrectal ultrasound and
prostate tissue biopsy, if clinically
indicated. Biopsy not required if
performed within 6 months of treatment
date.
- Mental capacity, dementia or inability to
give informed consent.
- Subject in retention, or with a previous
history of urinary retention.
- Post void residual volume >250 ml by
Ultrasound.
- Prostate gland with obstructive median
lobe or prominent bladder neck requiring
intervention.
- History of illness/symptoms or surgery
that may confound results of study, or
pose additional riskto subject.
- Patient with a life expectancy of less than
2 years
- Previous prostate surgery, dilation, stent,
laser, hyperthermia (ie non-
pharmaceutical prostate treatment).
- PSA > 10 ng/ml.
- Known, or suspected urological conditions
which may effect voiding function such
as confirmed or suspected malignancy
of the bladder or prostate, previous
pelvic irradiation or radical pelvic
surgery, neurogenic bladder and/or
sphincter abnormalities, cystolithiasis
or haematuria within 3 months,
urinarytract infection, urethral
strictures, bladder neck contracture,
active clinical prostatitis, bladder
pathologies or diabetes mellitus
affecting bladder function.
- Compromised renal function (serum
creatinine > 1.58 mg/l or > 0.1 mmol/L)
(ref: medcalc version 5.3 palm/os)
(medcalc.med-ia.net)
- Previous rectal surgery, other than
hemorrhoidectomy, that may have
distorted the pelvic anatomy, or any
implants in the pelvic/femoral
region.
- Subject interested in future fertility.
- Concomitant medications: beta-blockers,
antihistaminics, anticonvulsants, and
antispasmodics within 1 week of
treatment unless there is documented
evidence that the subject has been on
the same drug dose for at least 6
months with a stable voiding pattern
(the drug dose should not be altered or
discontinued for entrance into or
throughout the study).
- Anti-coagulant medication other than
acetylsalicylic acid (ASA) (aspirin) or
clopidogrel. ASA and clopidogrel must be
ceased 7 days prior to the procedure.
- 5-alpha-reductase inhibitors within 6
months of pre treatment evaluation
unless there is documented evidence
that the subject has been on the same
drug dose for at least 6 months with a
stable voiding pattern (The drug dose
should not be altered or discontinued
for entrance into or thourghout the
study).
- Antidepressants, anticholinergics, or
alpha-blockers within 1 week of the
pretreatment evaluation.
- Anti-androgens or gonadotropin-releasing
hormone (GnRH) analogs within 2
months of pretreatment evaluation.
- Any abnormal coagulopathy.
- Evidence of current urinary tract infection
(UTI)
- Evidence of current infectious process.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this study is to determine whether the transurethral placement of the NeoTract Anchor is feasible. This will be determined by the successful delivery of one or more devices and procedure completion. Successful device delivery can be visually confirmed via real-time camera images.[Intra-operative];The aim of this study is to determine whether the placement of the NeoTract anchor is safe, as determined by the absence of any serious adverse events reported either by the patient or observed by the investigator, relating to the procedure or to the anchoring devices themselves, either during the operation or in the follow-up period.[Intra-operative, 24 hours after procedure, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and annually thereafter for the 7 year duration.]
- Secondary Outcome Measures
Name Time Method