None listed
Conditions
Brief 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
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 transurethrally under endoscopic guidance.
The procedure duration is usually 90 minutes or less. Once implanted, the device remains permanently in place.
Sponsors
NeoTract, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 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 criteria
- 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.
Outcome results
None listed