For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has adverse effects on the latter. Current medical and surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery times, degradation of sexual function and incontinence may negatively affect a patient's QoL. Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving techniques with contrasting mechanisms of action (mechanical decompression vs angiographic embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar safety profiles. More importantly neither causes degradation of sexual function or urinary continence. Although multiple studies are being reported on PUL and PAE alike, currently there are no prospective clinical trials comparing these two technologies. We aim to prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could have a great impact on patient outcomes in men opting for minimally invasive, sexual function sparing treatment options for symptom relief from prostate enlargement.
As the population ages, there is a growing need to find ways for people to live longer with satisfactory quality of life (QoL), even in the midst of increasing health problems. For the ageing man, Health related quality of life ( HRQoL) is challenged by two common issues: the onset of bothersome LUTS attributable to benign prostatic hypertrophy (BPH) and diminishing ability to maintain normal sexual activity and function; both issues are important to men, yet often the treatment of the former has adverse effects on the latter. Current medical and surgical treatments like TURP for BPH offer symptomatic improvement of LUTS but may adversely affect a patient's QOL and satisfaction. Peri-operative complications and long recovery times, degradation of sexual function and iatrogenic incontinence may negatively affect a patient's QoL overall, resulting in patient viewing this as a treatment failure. Therefore when evaluating treatment options for BPH, treatment options with important QOL measures of satisfaction have to be considered. Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving techniques with contrasting mechanisms of action (mechanical decompression vs angiographic embolization). Multiple prospective and retrospective studies have shown that both PUL and PAE yield relief of lower urinary tract symptoms over a period of several weeks. They display similar safety profiles with self-limiting pelvic discomfort characterizing the commonest minor adverse event. Both procedures are minimally invasive and have the potential to be carried out under local anesthesia and in the outpatient setting with suitability for patients with cardiovascular comorbidities. Another important finding is that neither has been found to cause degradation of sexual function. Although there are an increasing number of data series being reported on PUL and PAE alike, currently there are no prospective clinical trials comparing these two technologies. We aim to prospectively evaluate and compare HRQol outcomes of PUL and PAE. All the endpoints will be evaluated using validated questionnaires and laboratory values. Results of this study will be transferable to clinical practice and could have a great impact on patient outcomes in men opting for minimally invasive, sexual function sparing treatment options for symptom relief from LUTS due to BPH in all practice settings.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
UroLift as artifical device for prostatic urethral lift. The PUL treatment is a minimally invasive approach to treating an enlarged prostate, or BPH, that lifts or holds the enlarged prostate tissue using clips so that it is out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue.
Embospheres Microspheres as embolic agents for prostate artery embolization Arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery to the prostate gland.Small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the enlarged prostate. The prostate is then expected to shrink , thus relieving urinary symptoms related to prostate enlargement.There is no cutting or removal of prostate tissue.Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.
Saint Louis University
St Louis, Missouri, United States
Improvement in QOL
Improvement in QOL score
Time frame: 3,6,12 months
Number of patients with clinical adverse events
Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications
Time frame: 1 day, 8 days and 1,3,6,12 months
Post operative morbidity
Morbidity (Intraprocedural and periprocedural data): Pain, hematuria, Procedure time, radiation parameters, duration of post procedure catheterization and hospitalization
Time frame: 1 day, 8 days and 1 month
Recovery experience
Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS)
Time frame: 1 day, 8 days and 1 month
Improvement in symptoms of LUTS
Reduction in International Prostate Symptom Score (IPSS) compared to baseline
Time frame: 3,6,12 months
Lack of change in sexual function
Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline
Time frame: 3,6,12 months
Lack of change in ejaculation during sex
Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD)
Time frame: 3,6,12 months
Lack of change in urinary incontinence
Change in Incontinence severity index (ISI) score
Time frame: 3,6,12 months
Change in Urinary flow after procedure
Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry.
Time frame: 3,6,12 months
Change in Prostate volume after procedure
Change in Prostate volume measured in cm3
Time frame: 3,6,12 months
Change in residual urine left in bladder after procedure
Change in Postvoid residual urine volume measured in ml
Time frame: 3,6,12 months
Change in Prostatic specific antigen (PSA) after procedure
Change in PSA level measured in pg/ml
Time frame: 3,6,12 months
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