RecruitingACTRN12609000760279

Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra: A Preliminary Investigation

Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra in males with benign prostatic hyperplasia: A Preliminary Investigation

Sponsor

NeoTract, Inc.

Enrollment

70 participants

Start Date

Dec 5, 2005

Study Type

Interventional

Conditions

Benign Prostatic Hyperplasia (BPH)

Summary

Luminal restoration of the prostatic urethra involves implanting the NeoTract Anchor System, which is designed to hold back the lobes of the prostate, and open the urethra (the tube that carries urine from your bladder to the outside of your body) to relieve symptoms associated with urinary obstruction. This study is a prospective, open-label feasibility study enrolling up to 70 participants. Safety and feasibility are the primary endpoints while patient questionnaires and therapeutic effectiveness is assessed as a secondary endpoint. Follow-up visits are at 24 hours, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year, and annually thereafter for the 7 year duration

Eligibility

Sex: MalesMin Age: 55 Yearss

Inclusion Criteria16

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.

Exclusion Criteria74

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
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.
-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.

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Interventions

The NeoTract Anchor System is a mechanical device that is designed to hold back the lobes of the prostate and relieve symptoms associated with urinary obstruction. The device is delivered transurethr

The NeoTract Anchor System is a mechanical device that is designed to hold back the lobes of the prostate and relieve symptoms associated with urinary obstruction. The device is delivered transurethrally under endoscopic guidance. The procedure duration is usually 90 minutes or less. Once implanted, the device remains permanently in place.