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).

Transurethral Resection of the Prostate (TURP) Clinical Trial

— UKROPE  

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02849522
• Other study ID #: UKROPE Register Study
• Status: Active, not recruiting
• Phase: N/A
• First received: July 26, 2016
• Last updated: August 3, 2016
• Start date: April 2014
• Est. completion date: September 2017

Study information

• Verified date: July 2016
• Source: Cedar, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational [Patient Registry]

Clinical 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 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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria for this registry study:

• 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

Exclusion Criteria for this registry study:

• Not able to read, write or understand English

• Not able/willing to provide informed written cons

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertrophy
• Laser Enucleation or Ablation of the Prostate
• Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE)
• Open Prostatectomy
• Prostate Artery Embolisation (PAE)
• Prostatic Hyperplasia
• Transurethral Resection of the Prostate (TURP)

Intervention

Procedure:
• Prostatic Artery Embolisation
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.
• TURP
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 prostatectomy
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 surgery
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Cedar, United Kingdom	British Association of Urological Surgeons (BAUS), British Society of Interventional Radiologists (BSIR), National Institute for Health and Care Excellence (NICE)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identify complications arising from PAE up to 12 months post-procedure	Identify complications arising from PAE up to 12 months post-procedure	12 months	Yes
Other	Subgroup analyses	Other areas of interest from this research are covered in the subgroup analyses, such as age or initial prostate volume. These subgroups will be cross-analysed with the various standard urological outcome measures such as Qmax and prostatic volume at 12 months post procedure. This will enable trends to be noted in particular subgroups, which may inform future research.	12 months	No
Other	Descriptive statistics for other outcome measures	Use descriptive statistics for other urological outcome measures e.g. IPSS for other comparator interventions (not TURP), 12 months post-procedure.	12 months	No
Primary	IPSS score change in PAE patients from baseline measurement	Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.	12 months	No
Secondary	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.	12 Months	No