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).

NCT02849522 | Unknown

• 1 other identifier: UKROPE Register Study
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• PAE non-inferiority to TURP 12 months post-procedure, using IPSS

  12 Months

Other Outcomes (3)

• Identify complications arising from PAE up to 12 months post-procedure

  12 months

• Subgroup analyses

  12 months

• Descriptive statistics for other outcome measures

  12 months

Study Arms (2)

PAE patients

Men who have undergone PAE and are in the UK ROPE Register

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.

Procedure: TURP; Procedure: Open prostatectomy; Procedure: Laser prostate surgery

Interventions

Prostatic Artery Embolisation PROCEDURE

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.

PAE patients

TURP PROCEDURE

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

Comparator treatment patients

Open prostatectomy PROCEDURE

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).

Comparator treatment patients

Laser prostate surgery PROCEDURE

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

Comparator treatment patients

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Not able to read, write or understand English
• Not able/willing to provide informed written cons

Sponsors & Collaborators

• Cedar, United Kingdom: lead
• National Institute for Health and Care Excellence (NICE): collaborator
• British Society of Interventional Radiologists (BSIR): collaborator
• British Association of Urological Surgeons (BAUS): collaborator

MeSH Terms

Interventions

Transurethral Resection of Prostate; Laser Therapy

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Therapeutics; Ablation Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 29, 2016
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 4, 2016

Record last verified: 2016-07