Acute Urinary Retention, Benign Prostatic Hyperplasia
Conditions
Keywords
Benign prostatic hyperplasia, BPH, Urinary retention, prostate, hypertrophy
Brief summary
Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).
Detailed description
The study is a multi-centre, prospective evaluation of PUL and retrospective review of invasive surgery as potential comparator. The study is intended to be conducted at up to 5 different centres in the United Kingdom to enrol up to 50 subjects. Subject follow-up visits are at post-procedure, 6 weeks, 3 months, 6 months and 12 months.
Interventions
DEVICEUroLift System Procedure
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
Sponsors
NeoTract, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
UroLift System Procedure Arm Inclusion Criteria: 1. Male gender 2. Diagnosis of symptomatic BPH 3. Age ≥ 50 years 4. Prostate volume ≤ 100 cc per ultrasound (US) 5. Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
Exclusion criteria
1. An obstructive or protruding median lobe of the prostate 2. Previous BPH surgical procedure 3. Previous pelvic surgery 4. Urethral conditions that prevents insertion and delivery of device system into bladder 5. Retention volume of \>1500 mL 6. Has not had prostate cancer excluded 7. History of prostate or bladder cancer 8. Biopsy of the prostate within the 6 weeks prior to Index Procedure 9. History of neurogenic or atonic bladder 10. Acute or chronic renal failure 11. Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA) 12. Known bladder stones within the prior 3 months or treatment within 12 months 13. Prostatitis requiring treatment (antibiotics) within the last year 14. Other co-morbidities that could impact the study results * severe cardiac arrhythmias uncontrolled by medications or pacemaker * congestive heart failure New York Heart Association (NYHA) III or IV * history of uncontrolled diabetes mellitus * significant respiratory disease in which hospitalisation may be required * known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) 15. Life expectancy estimated to be less than 5 years 16. Desire to maintain fertility post procedure 17. Unable or unwilling to complete all required questionnaires and follow up assessments 18. Unable or unwilling to sign informed consent form 19. Currently enroled in any other clinical research trial that has not completed the primary endpoint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Trial Without Catheter Peri-procedurally | 3 days (± 1 day) from index procedure | Success is defined as a spontaneous voided volume of ≥100 mL associated with a post void residual volume by ultrasound \<300 mL 3 days (± 1 day) after the index procedure catheter placement without the need for re-catheterisation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention | Through 3 months | Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device |
Countries
United Kingdom
Participant flow
Pre-assignment details
Retrospective cohort enrollment was separate from the 52 enrolled in the prospective cohort. Retrospective enrollment was based on a retrospective chart review between Jun 1, 2015 and December 31, 2015.
Participants by arm
| Arm | Count |
|---|---|
| UroLift System Procedure All eligible,enroled subjects will undergo a UroLift procedure.
UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH. | 52 |
| Retrospective Arm Chart review will be performed on all invasive BPH surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) performed by the site from June 1, 2015 to December 31, 2015 | 49 |
| Total | 101 |
Baseline characteristics
| Characteristic | UroLift System Procedure | Retrospective Arm | Total |
|---|---|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 7.9 | 72.7 years STANDARD_DEVIATION 8 | 72.0 years STANDARD_DEVIATION 8 |
| Duration of Lower Urinary Tract Symptoms (LUTS) >=10 years | 9 Participants | 6 Participants | 15 Participants |
| Duration of Lower Urinary Tract Symptoms (LUTS) 1-5 years | 19 Participants | 22 Participants | 41 Participants |
| Duration of Lower Urinary Tract Symptoms (LUTS) <1 year | 12 Participants | 18 Participants | 30 Participants |
| Duration of Lower Urinary Tract Symptoms (LUTS) 6-10 years | 12 Participants | 3 Participants | 15 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 52 participants | 49 participants | 101 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 52 Participants | 49 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 36 / 52 | 29 / 49 |
| serious Total, serious adverse events | 7 / 52 | 2 / 49 |
Outcome results
Primary
Successful Trial Without Catheter Peri-procedurally
Success is defined as a spontaneous voided volume of ≥100 mL associated with a post void residual volume by ultrasound \<300 mL 3 days (± 1 day) after the index procedure catheter placement without the need for re-catheterisation.
Time frame: 3 days (± 1 day) from index procedure
Population: Trial Without Catheter information for retrospective arm was recorded as available from medical record, information from the UroLift System was prospectively collected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UroLift System Procedure | Successful Trial Without Catheter Peri-procedurally | 29 Participants |
| Retrospective Arm | Successful Trial Without Catheter Peri-procedurally | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention
Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device
Time frame: Through 3 months
Population: Retrospective arm events were recorded from medical record and was not prospectively collected by sites compared to events collected prospectively from the UroLift System
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UroLift System Procedure | Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention | 4 Participants |
| Retrospective Arm | Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention | 1 Participants |