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CompletedNCT03194737Updated Jul 16, 2021Results posted

Prostatic Urethral Lift in Subject With Acute Urinary Retention

An interventional study of UroLift System Procedure in Acute Urinary Retention and Benign Prostatic Hyperplasia, sponsored by NeoTract, Inc.. Completed at 6 sites in United Kingdom. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by NeoTract, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Non-randomized
Ages
50 Years and older
Sex
Male
01

Study summary

Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).

Read the 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.

02

Conditions studied

  • Acute Urinary Retention
  • Benign Prostatic Hyperplasia

Keywords

  • Benign prostatic hyperplasia
  • BPH
  • Urinary retention
  • prostate
  • hypertrophy
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 101 is close to the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

NeoTract, Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

UroLift System Procedure Arm

Inclusion criteria

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    UroLift System procedure

    All eligible,enroled subjects will undergo a UroLift procedure.

    Device: UroLift System Procedure

  • No intervention
    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

Interventions

  • DeviceUroLift System Procedure

    Minimally invasive procedure in patients with acute urinary retention secondary to BPH.

    Also known as: Prostatic UroLift (PUL)

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Results

Posted Jul 16, 2021
Limitations and caveats
Data Retrospectively collected from the invasive Benign prostatic hyperplasia (BPH) surgeries (TURP, Holmium Laser Enucleation of the prostate (HoLEP), etc) was not directly comparable to the prospective UroLIFT system outcomes because of inherent standard of care differences between interventions, standard of care at sites and recording in medical records

Participant flow

Participant flow — Overall Study
MilestoneUroLift System ProcedureRetrospective Arm
Started5249
Completed4749
Not completed50

Outcome measures

PrimarySuccessful 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
Reported as:
Count of participants · Participants
Successful Trial Without Catheter Peri-procedurally
ParticipantsUroLift System ProcedureRetrospective Arm
Successful Trial Without Catheter Peri-procedurally290
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention
ParticipantsUroLift System ProcedureRetrospective Arm
Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention41

Adverse events

Collected over Index procedure and up to 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
UroLift System Procedure0/52 (0%)7/52 (13.5%)36/52 (69.2%)
Retrospective Arm0/49 (0%)2/49 (4.1%)29/49 (59.2%)
Most frequent serious events
Most frequent serious events
EventUroLift System ProcedureRetrospective Arm
HaematuriaRenal and urinary disorders2/521/49
Urinary tract infectionRenal and urinary disorders2/521/49
Blood clot in urineRenal and urinary disorders1/520/49
Intestinal bleedingGastrointestinal disorders1/520/49
Lucunar strokeNervous system disorders1/520/49
Most frequent other events
Most frequent other events
EventUroLift System ProcedureRetrospective Arm
HaematuriaRenal and urinary disorders6/5211/49
DysuriaRenal and urinary disorders9/520/49
Urinary tract infectionInfections and infestations9/523/49
Urinary urgencyRenal and urinary disorders0/528/49
Catheter site painInjury, poisoning and procedural complications5/521/49
Incontinence urgeRenal and urinary disorders5/522/49
Urinary frequency (Pollakiuria)Renal and urinary disorders1/524/49
Urinary retentionRenal and urinary disorders0/524/49
Pelvic PainRenal and urinary disorders4/523/49
Back PainMusculoskeletal and connective tissue disorders3/520/49

Baseline characteristics

Age, Continuous
Age, Continuous(years)UroLift System ProcedureRetrospective ArmTotal
Mean71.3 ± 7.972.7 ± 8.072.0 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)UroLift System ProcedureRetrospective ArmTotal
Female000
Male5249101
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)UroLift System ProcedureRetrospective ArmTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)UroLift System ProcedureRetrospective ArmTotal
United Kingdom5249101
Duration of Lower Urinary Tract Symptoms (LUTS)
Duration of Lower Urinary Tract Symptoms (LUTS)(Participants)UroLift System ProcedureRetrospective ArmTotal
<1 year121830
1-5 years192241
6-10 years12315
>=10 years9615
08

Study locations

6 sites
  • Freeman Hospital
    High Heaton, Newcastle Upon Tyne NE7 7DN, United Kingdom
  • Frimley Park Hospital
    Frimley, Surrey GU16 7UJ, United Kingdom
  • Addenbrooke's Hospital
    Cambridge, United Kingdom
  • St. James's University Hospital
    Leeds, United Kingdom
  • Central Middlesex Hospital
    London, United Kingdom
  • Norfolk and Norwich University Hospital
    Norwich, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 14, 2018
  • Informed consent form · Dec 14, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03194737
Lead sponsor
NeoTract, Inc.
Responsible party
Sponsor
First posted
Jun 21, 2017
Start date
Mar 24, 2018
Primary completion
Jan 21, 2019
Completion
Mar 3, 2020
Results posted
Jul 16, 2021
Last update
Jul 16, 2021

Study contacts

Neil Barber
principal investigator · Frimley Park Hospital
Oliver Kayes
principal investigator · St James's University Hosptial
Mark Rochester
principal investigator · Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Toby Page
principal investigator · Freeman Health System
Rajesh Kavia
principal investigator · Central Middlesex Hospital
Nikesh Thiruchelvam
principal investigator · Cambridge University Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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