An observational study in Lower Urinary Tract Symptoms Caused by Benign Prostatic Enlargement (LUTS BPE), Prostate Artery Embolisation (PAE) and Transurethral Resection of the Prostate (TURP), sponsored by Cedar, United Kingdom. Status unknown. Open to male participants. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by Cedar, United Kingdom · Observational
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:
Our hypothesis is:
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:
Secondary:
Our hypothesis is:
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)
406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's enrollment of 300 is above the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →This is the only study on the registry with Cedar, United Kingdom as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria for this registry study:
Men who have undergone PAE and are in the UK ROPE Register
Procedure: Prostatic Artery Embolisation
Men who have undergone TURP, Open Prostatectomy or laser ablation/enuclation of the prostate, and are on the UK ROPE Register.
Procedure: TURP · Procedure: Open prostatectomy · Procedure: Laser prostate 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.
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.
Also known as: Transurethral resection of the prostate
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).
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.
Also known as: HoLEP, KTP, GreenLight, Laser ablation, Laser enucleation
IPSS score change in PAE patients from baseline measurement
Assess the efficacy of PAE using the IPSS for LUTS BPE 12 months post-procedure.
Time frame: 12 months
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.
Time frame: 12 Months
Identify complications arising from PAE up to 12 months post-procedure
Identify complications arising from PAE up to 12 months post-procedure
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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