Urodynamic Feasibility Study (UDS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- NeoTract, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Qmax Assessed Using Urodynamic Testing (Cystometry)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male gender
- •Diagnosis of symptomatic BPH
- •Age ≥ 45 years
- •International Prostate Symptom Score (IPSS) ≥ 13
- •Peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml
- •Prostate volume ≤ 80 cc per ultrasound
Exclusion Criteria
- •Current urinary retention
- •Post void residual (PVR) urine \> 250 ml
- •Have an obstructive or protruding median lobe of the prostate
- •Active urinary tract infection at time of treatment
- •Current gross hematuria
- •Previous BPH surgical procedure
- •Previous pelvic surgery or irradiation
- •History of neurogenic or atonic bladder
- •Stress urinary incontinence
- •Biopsy of the prostate within the past 6 weeks
Outcomes
Primary Outcomes
Qmax Assessed Using Urodynamic Testing (Cystometry)
Time Frame: 3 Month
Qmax is the the maximum urinary flow rate measured in ml/s.
Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)
Time Frame: 3 Month
Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.
Pdetmax Assessed Using Urodynamic Testing (Cystometry)
Time Frame: 3 Month
Pdetmax is the maximum void pressure measured in cm H2O.