Trial Outcomes & Findings for Prostatic Urethral Lift in Subject With Acute Urinary Retention (NCT NCT03194737)
NCT ID: NCT03194737
Last Updated: 2021-07-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
3 days (± 1 day) from index procedure
Results posted on
2021-07-16
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
49
|
|
Overall Study
COMPLETED
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
UroLift System Procedure
n=52 Participants
All eligible,enroled subjects will undergo a UroLift procedure.
UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
|
Retrospective Arm
n=49 Participants
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
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 7.9 • n=52 Participants
|
72.7 years
STANDARD_DEVIATION 8.0 • n=49 Participants
|
72.0 years
STANDARD_DEVIATION 8.0 • n=101 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=52 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=52 Participants
|
49 Participants
n=49 Participants
|
101 Participants
n=101 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
52 participants
n=52 Participants
|
49 participants
n=49 Participants
|
101 participants
n=101 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS)
<1 year
|
12 Participants
n=52 Participants
|
18 Participants
n=49 Participants
|
30 Participants
n=101 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS)
1-5 years
|
19 Participants
n=52 Participants
|
22 Participants
n=49 Participants
|
41 Participants
n=101 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS)
6-10 years
|
12 Participants
n=52 Participants
|
3 Participants
n=49 Participants
|
15 Participants
n=101 Participants
|
|
Duration of Lower Urinary Tract Symptoms (LUTS)
>=10 years
|
9 Participants
n=52 Participants
|
6 Participants
n=49 Participants
|
15 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: 3 days (± 1 day) from index procedurePopulation: Trial Without Catheter information for retrospective arm was recorded as available from medical record, information from the UroLift System was prospectively collected
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.
Outcome measures
| Measure |
UroLift System Procedure
n=52 Participants
All eligible, enrolled subjects will undergo a UroLift procedure.
UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
|
Retrospective Arm
n=49 Participants
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
|
|---|---|---|
|
Successful Trial Without Catheter Peri-procedurally
|
29 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 3 monthsPopulation: Retrospective arm events were recorded from medical record and was not prospectively collected by sites compared to events collected prospectively from the UroLift System
Number of patients who experienced adjudicated Serious Adverse Events related to Benign prostatic hyperplasia (BPH) Intervention Procedure or Device
Outcome measures
| Measure |
UroLift System Procedure
n=52 Participants
All eligible, enrolled subjects will undergo a UroLift procedure.
UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
|
Retrospective Arm
n=49 Participants
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
|
|---|---|---|
|
Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention
|
4 Participants
|
1 Participants
|
Adverse Events
UroLift System Procedure
Serious events: 7 serious events
Other events: 36 other events
Deaths: 0 deaths
Retrospective Arm
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UroLift System Procedure
n=52 participants at risk
All eligible,enroled subjects will undergo a UroLift procedure.
UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
|
Retrospective Arm
n=49 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Haematuria
|
3.8%
2/52 • Number of events 2 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
2.0%
1/49 • Number of events 1 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Urinary tract infection
|
3.8%
2/52 • Number of events 2 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
2.0%
1/49 • Number of events 1 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Blood clot in urine
|
1.9%
1/52 • Number of events 1 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
0.00%
0/49 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Gastrointestinal disorders
Intestinal bleeding
|
1.9%
1/52 • Number of events 1 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
0.00%
0/49 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Nervous system disorders
Lucunar stroke
|
1.9%
1/52 • Number of events 1 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
0.00%
0/49 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
Other adverse events
| Measure |
UroLift System Procedure
n=52 participants at risk
All eligible,enroled subjects will undergo a UroLift procedure.
UroLift System Procedure: Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
|
Retrospective Arm
n=49 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Urinary frequency (Pollakiuria)
|
1.9%
1/52 • Number of events 1 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
8.2%
4/49 • Number of events 4 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Dysuria
|
17.3%
9/52 • Number of events 9 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
0.00%
0/49 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
3/52 • Number of events 3 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
0.00%
0/49 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Injury, poisoning and procedural complications
Catheter site pain
|
9.6%
5/52 • Number of events 5 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
2.0%
1/49 • Number of events 1 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Haematuria
|
11.5%
6/52 • Number of events 6 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
22.4%
11/49 • Number of events 11 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Incontinence urge
|
9.6%
5/52 • Number of events 5 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
4.1%
2/49 • Number of events 2 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Pelvic Pain
|
7.7%
4/52 • Number of events 4 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
6.1%
3/49 • Number of events 3 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Infections and infestations
Urinary tract infection
|
17.3%
9/52 • Number of events 13 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
6.1%
3/49 • Number of events 3 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/52 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
8.2%
4/49 • Number of events 4 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/52 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
16.3%
8/49 • Number of events 8 • Index procedure and up to 1 year
An AE is defined as any undesirable medical occurrence in a clinical trial subject, whether it is considered to be related to the device or not, that includes a clinical sign, symptom, or condition An (SAE) is defined as untoward occurrence that:(a) death; (b) life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation (d) results in persistent or significant disability or incapacity; or (e) is otherwise considered medically significant by the investigator
|
Additional Information
Emily Friedland, Director, Global Clinical Operations
Teleflex/NeoTract
Phone: 925.387.6014
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agreements restrict data disclosure until written agreement by or publication by Sponsor
- Publication restrictions are in place
Restriction type: OTHER