Acute Urinary RetentionNCT03194737

Prostatic Urethral Lift in Subject With Acute Urinary Retention

A study testing UroLift System Procedure in people with Acute Urinary Retention and Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Acute Urinary Retention, Benign Prostatic Hyperplasia
What is being tested?: UroLift System Procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 6 sitesUnited Kingdom
Study dates: 24 Mar 2018to 3 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male gender
Diagnosis of symptomatic BPH
Age ≥ 50 years
Prostate volume ≤ 100 cc per ultrasound (US)
Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker

Who cannot join

An obstructive or protruding median lobe of the prostate
Previous BPH surgical procedure
Previous pelvic surgery
Urethral conditions that prevents insertion and delivery of device system into bladder
Retention volume of >1500 mL
Has not had prostate cancer excluded

Show all 24Show fewer

History of prostate or bladder cancer
Biopsy of the prostate within the 6 weeks prior to Index Procedure
History of neurogenic or atonic bladder
Acute or chronic renal failure
Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA)
Known bladder stones within the prior 3 months or treatment within 12 months
Prostatitis requiring treatment (antibiotics) within the last year
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)
Life expectancy estimated to be less than 5 years
Desire to maintain fertility post procedure
Unable or unwilling to complete all required questionnaires and follow up assessments
Unable or unwilling to sign informed consent form
Currently enroled in any other clinical research trial that has not completed the primary endpoint

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United Kingdom6 sites

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

Other trials in United Kingdom

About this study

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.

Conditions: Acute Urinary Retention, Benign Prostatic Hyperplasia
Being tested: UroLift System Procedure
Keywords: Benign prostatic hyperplasia, BPH, Urinary retention, prostate, hypertrophy
Medical subject headings: Prostatic Hyperplasia, Urinary Retention, Hypertrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UroLift System ProcedureDevice
Also called Prostatic UroLift (PUL)
Minimally invasive procedure in patients with acute urinary retention secondary to BPH.

Study groups in NCT03194737
Study group	Role	What they receive
UroLift System procedure	Experimental	All eligible,enroled subjects will undergo a UroLift procedure. Receives: Device: UroLift System Procedure
Retrospective Arm	No intervention	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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: Through 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 20183 Mar 2020

First posted21 Jun 2017
Study start24 Mar 2018
Primary completion21 Jan 2019
Study completion3 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Urinary RetentionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03194737
Sponsor's protocol ID: CP00004
Status last verified: May 2021
First submitted: 19 Jun 2017
Last updated: 16 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
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Not yet recruitingPhase 2
Study of Teverelix DP on Prostate Volume, Urinary Function and Clinical Outcomes Following Acute Urinary Retention
Acute Urinary Retention, Benign Prostate Hypertrophy(BPH)
RecruitingPhase 4
Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia
Acute Urinary Retention, Benign Prostatic Hyperplasia
RecruitingPhase 4
Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention
Acute Urinary Retention, Benign Prostatic Hyperplasia
Active, not recruiting
How the Method of Bladder Emptying After Epidural Placement in Labor Affects Postpartum Voiding
Urinary Retention, Urinary Tract Infection (Diagnosis)

All Acute Urinary Retention trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prostatic Urethral Lift in Subject With Acute Urinary Retention
ClinicalTrials.gov ID: NCT03194737
Acronym / sponsor ID: CP00004
Conditions: Acute Urinary Retention, Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia, BPH, Urinary retention, prostate, hypertrophy
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: NeoTract, Inc.Industry (pharma, biotech, devices)
Study start: 24 Mar 2018 (actual)
Primary completion: 21 Jan 2019 (actual)
Study completion: 3 Mar 2020 (actual)
First posted: 21 Jun 2017 (actual)
Results: Posted 16 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
UroLift System procedure	Experimental	Device: UroLift System ProcedureAll eligible,enroled subjects will undergo a UroLift procedure.
Retrospective Arm	No intervention	–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

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male gender
Diagnosis of symptomatic BPH
Age ≥ 50 years
Prostate volume ≤ 100 cc per ultrasound (US)
Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker

Key exclusion criteria (24 listed)

An obstructive or protruding median lobe of the prostate
Previous BPH surgical procedure
Previous pelvic surgery
Urethral conditions that prevents insertion and delivery of device system into bladder
Retention volume of >1500 mL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UroLift System ProcedureAlso: Prostatic UroLift (PUL)Minimally invasive procedure in patients with acute urinary retention secondary to BPH.	Device	UroLift System procedure

Primary outcome

Successful Trial Without Catheter Peri-procedurally
Time frame: 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.

1 secondary outcome

Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention
Time frame: Through 3 months

Results and safety

Results posted to the registry on 16 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UroLift System Procedure	52	47
Retrospective Arm	49	49

Primary outcome: Successful Trial Without Catheter Peri-procedurally

Time frame: 3 days (± 1 day) from index procedure. Count of participants. Unit: Participants

Measure	UroLift System Procedure n = 52	Retrospective Arm n = 49
Value	29	0

Population analysed: Trial Without Catheter information for retrospective arm was recorded as available from medical record, information from the UroLift System was prospectively collected

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Index procedure and up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UroLift System Procedure	7 of 52 (13.5%)	36 of 52 (69.2%)	0 of 52
Retrospective Arm	2 of 49 (4.1%)	29 of 49 (59.2%)	0 of 49

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Urinary Retention

RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Urinary Retention, Benign Prostate Obstruction (BPO)
Not yet recruitingPhase 2
Study of Teverelix DP on Prostate Volume, Urinary Function and Clinical Outcomes Following Acute Urinary Retention
Acute Urinary Retention, Benign Prostate Hypertrophy(BPH)
RecruitingPhase 4
Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia
Acute Urinary Retention, Benign Prostatic Hyperplasia
RecruitingPhase 4
Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention
Acute Urinary Retention, Benign Prostatic Hyperplasia
Active, not recruiting
How the Method of Bladder Emptying After Epidural Placement in Labor Affects Postpartum Voiding
Urinary Retention, Urinary Tract Infection (Diagnosis)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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)

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing UroLift System Procedure in people with Acute Urinary Retention and Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Trial Without Catheter Peri-procedurally (time frame: 3 days (± 1 day) from index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.