Transurethral Resection of the Prostate (TURP) Clinical Trial
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).
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
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)
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01091779 -
Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for Transurethral Resection of the Prostate (TURP) Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients
|
N/A |