Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE)UKROPENCT02849522
ROPE Registry Project to Determine the Safety and Efficacy of Prostate Artery Embolisation (PAE) for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Enlargement (LUTS BPE).
An observational study of Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE) and Prostate Artery Embolisation (PAE), run by Cedar, United Kingdom.
Trial summary
This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS). This register enables us to collect data on the treatment of LUTS using prostate artery embolisation (PAE), and other surgical methods to answer the following questions posed by NICE in 2013: Is PAE a safe and effective… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE), Prostate Artery Embolisation (PAE), Transurethral Resection of the Prostate (TURP)
- What is being tested?
- Prostatic Artery Embolisation, TURP and Open prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Sep 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: It should be noted that the dissemination of the PAE procedure in the UK is separate to this registry study. Therefore, the inclusion criteria for this registry study are all patients who have had PAE or one of the comparator interventions (TURP, open prostatectomy or laser surgery) in one of the participating hospitals. and outline of the inclusion/exclusion guidelines for participating hospitals is shown below: Inclusions for patient selection at participating hospital: Age 50-75 Moderate to severe LUTS Prostate volume ≥ 40 ml Maximum urinary flow rate < 12ml/s Unsuccessful drug therapy for ≥ 6 months Exclusions for patient selection at participating hospital: Atherosclerosis of the prostatic arteries Bladder diverticula or stone Urethral stenosis Neurogenic bladder eGFR ≤ 45ml min-1m-2 Malignancy (on biopsy)
Who may be able to join
- Men with LUTS who have consented for PAE, TURP, open prostatectomy or laser surgery at a participating site
- Able to read, write and understand English
- Capable of giving informed written consent
Who cannot join
- Not able to read, write or understand English
- Not able/willing to provide informed written cons
About this study
This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS). This register enables us to collect data on the treatment of LUTS using prostate artery embolisation (PAE), and other surgical methods to answer the following questions posed by NICE in 2013:
- Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?
- How does PAE compare with conventional surgical treatments? This will primarily be a surgical procedure called TURP (see below).
- Which patients would most benefit from PAE over the other treatment options? This is a pilot study, and the final register will contain data from roughly 100 patients for PAE and 100 patients for the other surgical interventions, allowing us to answer NICE's research questions, update NICE guidance documentation, and do further research with more patients if necessary.
Read more
Our hypothesis is:
- PAE produces significant improvements in the IPSS score 12 months post-procedure
Read the detailed description
This is a pilot study, intended to collect observational data on the PAE procedure as it is disseminated and performed around the UK, and on other comparator interventions. The aim is to give NICE enough information to potentially update their Interventional Procedures Guidance and may form the grounding for further research in the shape of a larger randomised clinical trial.
The ROPE Register project aims are to:
Primary:
- Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.
Secondary:
- Compare PAE to TURP (using IPSS score) for LUTS BPE 12 months post-procedure. This will be a non-inferiority study for PAE versus TURP. A non-inferiority approach has been chosen because if PAE is no worse in terms of outcome for the patient, but is a more acceptable procedure to the patient (or has fewer complications, is less invasive, etc) than TURP, then PAE would be preferable.
- Use descriptive statistics for other outcome measures (IPSS, IPSS QoL, IIEF, prostate volume and urinary flow studies) for other comparator interventions (not TURP), 12 months post-procedure.
- Identify complications arising from PAE up to 12 months post-procedure.
- Elucidate which subgroup (s) of patients would benefit the most from PAE as a treatment option.
Our hypothesis is:
- PAE produces significant improvements in the IPSS score 12 months post-procedure
Additional subgroup analyses:
Other areas of interest from this research are covered in the subgroup analyses. The tables below detail the PAE patient subgroups that will be analysed. These subgroups will be cross-analysed with the measures in the Outcome measures table. This will enable trends to be noted in particular subgroups, which may inform future research.
Subgroups:
Age Baseline IPSS score Baseline Prostate Volume
Outcome measures:
IPSS Score IPSS Quality of Life Score IIEF score Prostate Volume Urinary flow study (Qmax, post-void residual volume, duration of micturition)
- Conditions
- Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE), Prostate Artery Embolisation (PAE), Transurethral Resection of the Prostate (TURP), Open Prostatectomy, Laser Enucleation or Ablation of the Prostate
- Being tested
- Prostatic Artery Embolisation, TURP, Open prostatectomy, Laser prostate surgery
- Keywords
- Lower Urinary Tract Symptoms caused by Benign Prostatic Enlargement (LUTS BPE), Prostate Artery Embolisation (PAE), Transurethral Resection of the Prostate (TURP), Open prostatectomy, Laser enucleation or ablation of the prostate (Green Light, KTP, HoLEP), IPSS Score, IIEF Score, Complications, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery EmbolisationProcedure or surgery
The aim of PAE for LUTS (due to BPH) is to reduce the blood supply of the prostate gland, causing some of it to undergo necrosis with subsequent shrinkage.
The procedure is usually performed with the patient under local anaesthetic and sedation. Using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation involves the introduction of microparticles to block these small prostatic arteries. Embolisation agents include polyvinyl alcohol (PVA), gelatine sponge and other synthetic biocompatible materials.
NICE published Interventional Procedures Guidance (IPG453) in April 2013. The evidence at the time of assessment was deemed inadequate in quantity and quality. Therefore, the procedure was given a 'Research-only' recommendation.
TURPProcedure or surgery
Also called Transurethral resection of the prostate
Transurethral resection of the prostate. A cystoscope is passed up the urethra to the prostate, where the surrounding prostate tissue is excised. This is a common operation for benign prostatic hyperplasia (BPH), with around 15,000 procedures performed in the UK per year (NHS Choices). The conventional TURP method of tissue removal utilizes a wire loop with electrical current flowing in one direction (monopolar) through the resectoscope to cut the tissue. Bipolar TURP allows saline irrigation and eliminates the need for an ESU grounding pad thus preventing TUR syndrome and reducing other complications.
Open prostatectomyProcedure or surgery
In an open prostatectomy the prostate is accessed through an incision that allows manual manipulation and open visualization through the incision. The most common types of open prostatectomy are retropubic prostatectomy (RP) or transvesical prostatectomy (TVP).
Laser prostate surgeryProcedure or surgery
Also called HoLEP, KTP, GreenLight, Laser ablation
This surgical method (HoLEP or KTP/"Greenlight") utilizes laser energy to remove tissue. With laser prostate surgery a laser fibre inserted via an endoscope is used to transmit laser energy to enucleate (HoLEP) or vaporise (KTP) the tissue. The specific advantages of utilizing laser energy rather than a traditional electrosurgical TURP is a decrease in the relative blood loss, elimination of the risk of TUR syndrome, the ability to treat larger glands, as well as treating patients who are actively being treated with anti-coagulation therapy for unrelated diagnoses.
| Study group | Role | What they receive |
|---|---|---|
| PAE patients | Men who have undergone PAE and are in the UK ROPE Register Receives: Procedure: Prostatic Artery Embolisation | |
| Comparator treatment patients | Men who have undergone TURP, Open Prostatectomy or laser ablation/enuclation of the prostate, and are on the UK ROPE Register. Receives: Procedure: TURP; Procedure: Open prostatectomy; Procedure: Laser prostate surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS score change in PAE patients from baseline measurement
Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.
Measured: 12 months
Secondary outcomes (1)
PAE non-inferiority to TURP 12 months post-procedure, using IPSS
Compare PAE to TURP (using IPSS score) for LUTS BPE 12 months post-procedure. This will be a non-inferiority study for PAE versus TURP. A non-inferiority approach has been chosen because if PAE is no worse in terms of outcome for the patient, but is a more acceptable procedure to the patient (or has fewer complications, is less invasive, etc) than TURP, then PAE would be preferable.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startApr 2014
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cedar, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health and Care Excellence (NICE), British Society of Interventional Radiologists (BSIR), British Association of Urological Surgeons (BAUS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849522
- Sponsor's protocol ID
- UKROPE Register Study
- Acronym
- UKROPE
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROPE Registry Project to Determine the Safety and Efficacy of Prostate Artery Embolisation (PAE) for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Enlargement (LUTS BPE).
- ClinicalTrials.gov ID
- NCT02849522
- Acronym / sponsor ID
- UKROPE / UKROPE Register Study
- Conditions
- Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE), Prostate Artery Embolisation (PAE), Transurethral Resection of the Prostate (TURP), Open Prostatectomy, Laser Enucleation or Ablation of the Prostate
- Keywords
- Lower Urinary Tract Symptoms caused by Benign Prostatic Enlargement (LUTS BPE), Prostate Artery Embolisation (PAE), Transurethral Resection of the Prostate (TURP), Open prostatectomy, Laser enucleation or ablation of the prostate (Green Light, KTP, HoLEP), IPSS Score, IIEF Score, Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cedar, United KingdomUniversity, hospital or other
- Collaborators
- National Institute for Health and Care Excellence (NICE), British Society of Interventional Radiologists (BSIR), British Association of Urological Surgeons (BAUS)
- Study start
- Apr 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS). This register enables us to collect data on the treatment of LUTS using prostate artery embolisation (PAE), and other surgical methods to answer the following questions posed by NICE in 2013:
- Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?
- How does PAE compare with conventional surgical treatments? This will primarily be a surgical procedure called TURP (see below).
- Which patients would most benefit from PAE over the other treatment options? This is a pilot study, and the final register will contain data from roughly 100 patients for PAE and 100 patients for the other surgical interventions, allowing us to answer NICE's research questions, update NICE guidance documentation, and do further research with more patients if necessary.
Our hypothesis is:
- PAE produces significant improvements in the IPSS score 12 months post-procedure
Detailed description
This is a pilot study, intended to collect observational data on the PAE procedure as it is disseminated and performed around the UK, and on other comparator interventions. The aim is to give NICE enough information to potentially update their Interventional Procedures Guidance and may form the grounding for further research in the shape of a larger randomised clinical trial.
The ROPE Register project aims are to:
Primary:
- Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.
Secondary:
- Compare PAE to TURP (using IPSS score) for LUTS BPE 12 months post-procedure. This will be a non-inferiority study for PAE versus TURP. A non-inferiority approach has been chosen because if PAE is no worse in terms of outcome for the patient, but is a more acceptable procedure to the patient (or has fewer complications, is less invasive, etc) than TURP, then PAE would be preferable.
- Use descriptive statistics for other outcome measures (IPSS, IPSS QoL, IIEF, prostate volume and urinary flow studies) for other comparator interventions (not TURP), 12 months post-procedure.
- Identify complications arising from PAE up to 12 months post-procedure.
- Elucidate which subgroup (s) of patients would benefit the most from PAE as a treatment option.
Our hypothesis is:
- PAE produces significant improvements in the IPSS score 12 months post-procedure
Additional subgroup analyses:
Other areas of interest from this research are covered in the subgroup analyses. The tables below detail the PAE patient subgroups that will be analysed. These subgroups will be cross-analysed with the measures in the Outcome measures table. This will enable trends to be noted in particular subgroups, which may inform future research.
Subgroups:
Age Baseline IPSS score Baseline Prostate Volume
Outcome measures:
IPSS Score IPSS Quality of Life Score IIEF score Prostate Volume Urinary flow study (Qmax, post-void residual volume, duration of micturition)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAE patients | – | Procedure: Prostatic Artery EmbolisationMen who have undergone PAE and are in the UK ROPE Register |
| Comparator treatment patients | – | Procedure: TURP, Procedure: Open prostatectomy, Procedure: Laser prostate surgeryMen who have undergone TURP, Open Prostatectomy or laser ablation/enuclation of the prostate, and are on the UK ROPE Register. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It should be noted that the dissemination of the PAE procedure in the UK is separate to this registry study. Therefore, the inclusion criteria for this registry study are all patients who have had PAE or one of the comparator interventions (TURP, open prostatectomy or laser surgery) in one of the participating hospitals. and outline of the inclusion/exclusion guidelines for participating hospitals is shown below: Inclusions for patient selection at participating hospital: Age 50-75 Moderate to severe LUTS Prostate volume ≥ 40 ml Maximum urinary flow rate < 12ml/s Unsuccessful drug therapy for ≥ 6 months Exclusions for patient selection at participating hospital: Atherosclerosis of the prostatic arteries Bladder diverticula or stone Urethral stenosis Neurogenic bladder eGFR ≤ 45ml min-1m-2 Malignancy (on biopsy)
Key inclusion criteria (3 listed)
- Men with LUTS who have consented for PAE, TURP, open prostatectomy or laser surgery at a participating site
- Able to read, write and understand English
- Capable of giving informed written consent
Key exclusion criteria (2 listed)
- Not able to read, write or understand English
- Not able/willing to provide informed written cons
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 |
|---|---|---|
| Prostatic Artery EmbolisationThe aim of PAE for LUTS (due to BPH) is to reduce the blood supply of the prostate gland, causing some of it to undergo necrosis with subsequent shrinkage. The procedure is usually performed with the patient under local anaesthetic and sedation. Using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation involves the introduction of microparticles to block these small prostatic arteries. Embolisation agents include polyvinyl alcohol (PVA), gelatine sponge and other synthetic biocompatible materials. NICE published Interventional Procedures Guidance (IPG453) in April 2013. The evidence at the time of assessment was deemed inadequate in quantity and quality. Therefore, the procedure was given a 'Research-only' recommendation. | Procedure or surgery | PAE patients |
| TURPAlso: Transurethral resection of the prostateTransurethral resection of the prostate. A cystoscope is passed up the urethra to the prostate, where the surrounding prostate tissue is excised. This is a common operation for benign prostatic hyperplasia (BPH), with around 15,000 procedures performed in the UK per year (NHS Choices). The conventional TURP method of tissue removal utilizes a wire loop with electrical current flowing in one direction (monopolar) through the resectoscope to cut the tissue. Bipolar TURP allows saline irrigation and eliminates the need for an ESU grounding pad thus preventing TUR syndrome and reducing other complications. | Procedure or surgery | Comparator treatment patients |
| Open prostatectomyIn an open prostatectomy the prostate is accessed through an incision that allows manual manipulation and open visualization through the incision. The most common types of open prostatectomy are retropubic prostatectomy (RP) or transvesical prostatectomy (TVP). | Procedure or surgery | Comparator treatment patients |
| Laser prostate surgeryAlso: HoLEP, KTP, GreenLight, Laser ablationThis surgical method (HoLEP or KTP/"Greenlight") utilizes laser energy to remove tissue. With laser prostate surgery a laser fibre inserted via an endoscope is used to transmit laser energy to enucleate (HoLEP) or vaporise (KTP) the tissue. The specific advantages of utilizing laser energy rather than a traditional electrosurgical TURP is a decrease in the relative blood loss, elimination of the risk of TUR syndrome, the ability to treat larger glands, as well as treating patients who are actively being treated with anti-coagulation therapy for unrelated diagnoses. | Procedure or surgery | Comparator treatment patients |
Primary outcome
IPSS score change in PAE patients from baseline measurement
Time frame: 12 months
Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.
1 secondary outcome
PAE non-inferiority to TURP 12 months post-procedure, using IPSS
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE) and Prostate Artery Embolisation (PAE), run by Cedar, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
IPSS score change in PAE patients from baseline measurement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2016.