Benign Prostatic Hyperplasia
Conditions
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.
Interventions
DEVICEUroLift
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
Sponsors
NeoTract, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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 * Life expectancy estimated to be less than 1 year * History of prostate or bladder cancer * Elevated Prostate-Specific Antigen (PSA) without ruling out prostate cancer * History of compromised renal function or upper tract disease * Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure) * Use of the following medications pre-screening (uroflow, questionnaires): * Within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids * Within 3 months of baseline assessment: 5-alpha-reductase inhibitors * Within 2 weeks of baseline assessment: alpha-blockers, gonadotropin-releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, or imipramine medications * Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics * Cystolithiasis within the prior 3 months * History of co-morbidities that would affect having an elective urological procedure including: prostatitis, conditions that preclude the insertion of the UroLift System. * Other co-morbidities that could impact the study results such as: * Severe cardiac arrhythmias uncontrolled by medications or pacemaker * Congestive heart failure New York Heart Assocation (NYHA) III or IV * History of uncontrolled diabetes mellitus * Significant respiratory disease in which hospitalization may be required * Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) * A known allergy to nickel, titanium, or stainless steel * Unable or unwilling to complete all required questionnaires and follow up assessments * Unable or unwilling to sign informed consent form * Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qmax Assessed Using Urodynamic Testing (Cystometry) | 3 Month | Qmax is the the maximum urinary flow rate measured in ml/s. |
| Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry) | 3 Month | Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O. |
| Pdetmax Assessed Using Urodynamic Testing (Cystometry) | 3 Month | Pdetmax is the maximum void pressure measured in cm H2O. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UroLift UroLift: The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).
During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | UroLift | — |
|---|---|---|
| Age, Customized Age | 57.44 years STANDARD_DEVIATION 6.33 | — |
| Pdetmax | 108.9 cmH20 STANDARD_DEVIATION 34.4 | — |
| Pdet @ Qmax | 79.9 cmH20 STANDARD_DEVIATION 25.2 | — |
| Qmax | 7.0 mL/sec STANDARD_DEVIATION 2.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)
Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.
Time frame: 3 Month
Population: Overall number of participants analyzed is fewer than the total number of participants (12) and number of participants analyzed at baseline (8) because unable to interpret data collected at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UroLift | Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry) | 82.4 cm H2O | Standard Deviation 21.9 |
Primary
Pdetmax Assessed Using Urodynamic Testing (Cystometry)
Pdetmax is the maximum void pressure measured in cm H2O.
Time frame: 3 Month
Population: Overall number of participants analyzed is fewer than the total number of participants (12) and number of participants analyzed at baseline (8) because unable to interpret data collected at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UroLift | Pdetmax Assessed Using Urodynamic Testing (Cystometry) | 101.5 cm H2O | Standard Deviation 30.7 |
Primary
Qmax Assessed Using Urodynamic Testing (Cystometry)
Qmax is the the maximum urinary flow rate measured in ml/s.
Time frame: 3 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UroLift | Qmax Assessed Using Urodynamic Testing (Cystometry) | 14.0 mL/sec | Standard Deviation 8.4 |