Clinical trial NCT02849522: 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).
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).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Quality of Life
Lead sponsor: Cedar, United Kingdom
Sponsor class: OTHER
Collaborators: name: National Institute for Health and Care Excellence (NICE)
name: British Society of Interventional Radiologists (BSIR)
name: British Association of Urological Surgeons (BAUS)
First posted: 2016-07-29
Enrollment: 300
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: IPSS score change in PAE patients from baseline measurement
timeFrame: 12 months
Secondary outcomes:
measure: PAE non-inferiority to TURP 12 months post-procedure, using IPSS
timeFrame: 12 Months
Other outcomes:
measure: Identify complications arising from PAE up to 12 months post-procedure
timeFrame: 12 months
measure: Subgroup analyses
timeFrame: 12 months
measure: Descriptive statistics for other outcome measures
timeFrame: 12 months
Locations:
Study officials:
References: