Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Prostatic Urethral Lift (PUL) Versus Prostate Arterial Embolization (PAE),Novel Minimally Invasive Treatment Options on Health-related Quality of Life (HRQoL) in Men With Lower Urinary Tract Symptoms Secondary to BPH.

Conditions
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Frequency/Urgency, Urinary Incontinence, Urge, Incontinence, Urinary, Nocturia

Intervention / Treatment
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* Device: UroLift as artifical device for prostatic urethral lift.
* Device: Embospheres Microspheres as embolic agents for prostate artery embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male aged ≥40 yr Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study Diagnosis of urinary symptoms (LUTS) from prostatic enlargement (BPH) refractory to medical therapy for at least 6 months. International Prostate Symptom Score >12 Exclusion Criteria: PUL Active urinary tract infections, prostatitis, or interstitial cystitis. Biopsy proven prostate, bladder, or urethral cancer. The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study: Patients with digital rectal examination (DRE) findings suspicious for prostate cancer Patients with baseline PSA levels > 10 ng/mL Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study Significant median lobe enlargement. Large prostates, volume >80 g. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.) Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder diverticulum, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition Urethral conditions that may prevent insertion of a rigid 20F cystoscope Current urinary retention. Acontractile detrusor. Current gross hematuria Known upper tract renal disease Cystolithiasis ASA > 3 or severe medical debilitating condition History of pelvic irradiation or radical pelvic surgery Known allergy to nickel. PAE Active urinary tract infections, prostatitis, or interstitial cystitis. Biopsy proven prostate, bladder, or urethral cancer. The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study: Patients with digital rectal examination (DRE) findings suspicious for prostate cancer Patients with baseline PSA levels > 10 ng/mL Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study Unable to have CT angio of the prostate imaging Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.) Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder diverticulum, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition Acontractile detrusor. Known upper tract renal disease Cystolithiasis Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis. Known major iliac arterial occlusive disease ASA > 3 or severe medical debilitating condition Baseline serum creatinine level > 1.8 mg/dl Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease History of pelvic irradiation or radical pelvic surgery Allergy to iodinated contrast agents

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAE-Prostate Arterial Embolization<br>PAE-Prostate Arterial Embolization | Device: UroLift as artifical device for prostatic urethral lift.<br>* 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.<br>* Other names: Prostatic urethral lift.;Device: Embospheres Microspheres as embolic agents for prostate artery embolization<br>* 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.<br>* Other names: Prostate artery embolization;|
| Active Comparator: PUL- Prostatic urethral lift<br>PUL- Prostatic urethral lift | Device: UroLift as artifical device for prostatic urethral lift.<br>* 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.<br>* Other names: Prostatic urethral lift.;Device: Embospheres Microspheres as embolic agents for prostate artery embolization<br>* 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.<br>* Other names: Prostate artery embolization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in QOL | Improvement in QOL score | 3,6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with clinical adverse events | Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications | 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 | 1 day, 8 days and 1 month | 
| Recovery experience | Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS) | 1 day, 8 days and 1 month | 
| Improvement in symptoms of LUTS | Reduction in International Prostate Symptom Score (IPSS) compared to baseline | 3,6,12 months | 
| Lack of change in sexual function | Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline | 3,6,12 months | 
| Lack of change in ejaculation during sex | Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD) | 3,6,12 months | 
| Lack of change in urinary incontinence | Change in Incontinence severity index (ISI) score | 3,6,12 months | 
| Change in Urinary flow after procedure | Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry. | 3,6,12 months | 
| Change in Prostate volume after procedure | Change in Prostate volume measured in cm3 | 3,6,12 months | 
| Change in residual urine left in bladder after procedure | Change in Postvoid residual urine volume measured in ml | 3,6,12 months | 
| Change in Prostatic specific antigen (PSA) after procedure | Change in PSA level measured in pg/ml | 3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate artery embolization, Prostatic Urethral Lift, Urolift, Minimally invasive, non-surgical, maintenance of sexual function, complications of TURP , surgery