Back to resultsInnovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men
Primary Purpose
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Frequency/Urgency
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UroLift as artifical device for prostatic urethral lift.
Embospheres Microspheres as embolic agents for prostate artery embolization
Sponsored by
About this trial
This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring prostate artery embolization, Prostatic Urethral Lift, Urolift, Minimally invasive, non-surgical, maintenance of sexual function, complications of TURP , surgery
Eligibility Criteria
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
Sites / Locations
- Saint Louis University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PAE-Prostate Arterial Embolization
PUL- Prostatic urethral lift
Arm Description
PAE-Prostate Arterial Embolization
PUL- Prostatic urethral lift
Outcomes
Primary Outcome Measures
Improvement in QOL
Improvement in QOL score
Secondary Outcome Measures
Number of patients with clinical adverse events
Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications
Post operative morbidity
Morbidity (Intraprocedural and periprocedural data): Pain, hematuria, Procedure time, radiation parameters, duration of post procedure catheterization and hospitalization
Recovery experience
Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS)
Improvement in symptoms of LUTS
Reduction in International Prostate Symptom Score (IPSS) compared to baseline
Lack of change in sexual function
Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline
Lack of change in ejaculation during sex
Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD)
Lack of change in urinary incontinence
Change in Incontinence severity index (ISI) score
Change in Urinary flow after procedure
Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry.
Change in Prostate volume after procedure
Change in Prostate volume measured in cm3
Change in residual urine left in bladder after procedure
Change in Postvoid residual urine volume measured in ml
Change in Prostatic specific antigen (PSA) after procedure
Change in PSA level measured in pg/ml
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03043222
Brief Title
Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn from IRB
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Frequency/Urgency, Urinary Incontinence, Urge, Incontinence, Urinary, Nocturia
Keywords
prostate artery embolization, Prostatic Urethral Lift, Urolift, Minimally invasive, non-surgical, maintenance of sexual function, complications of TURP , surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAE-Prostate Arterial Embolization
Arm Type
Experimental
Arm Description
PAE-Prostate Arterial Embolization
Arm Title
PUL- Prostatic urethral lift
Arm Type
Active Comparator
Arm Description
PUL- Prostatic urethral lift
Intervention Type
Device
Intervention Name(s)
UroLift as artifical device for prostatic urethral lift.
Other Intervention Name(s)
Prostatic urethral lift.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Embospheres Microspheres as embolic agents for prostate artery embolization
Other Intervention Name(s)
Prostate artery embolization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in QOL
Description
Improvement in QOL score
Time Frame
3,6,12 months
Secondary Outcome Measure Information:
Title
Number of patients with clinical adverse events
Description
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
Title
Post operative morbidity
Description
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
Title
Recovery experience
Description
Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS)
Time Frame
1 day, 8 days and 1 month
Title
Improvement in symptoms of LUTS
Description
Reduction in International Prostate Symptom Score (IPSS) compared to baseline
Time Frame
3,6,12 months
Title
Lack of change in sexual function
Description
Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline
Time Frame
3,6,12 months
Title
Lack of change in ejaculation during sex
Description
Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD)
Time Frame
3,6,12 months
Title
Lack of change in urinary incontinence
Description
Change in Incontinence severity index (ISI) score
Time Frame
3,6,12 months
Title
Change in Urinary flow after procedure
Description
Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry.
Time Frame
3,6,12 months
Title
Change in Prostate volume after procedure
Description
Change in Prostate volume measured in cm3
Time Frame
3,6,12 months
Title
Change in residual urine left in bladder after procedure
Description
Change in Postvoid residual urine volume measured in ml
Time Frame
3,6,12 months
Title
Change in Prostatic specific antigen (PSA) after procedure
Description
Change in PSA level measured in pg/ml
Time Frame
3,6,12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Pereira, MD
Organizational Affiliation
Saint Louis University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beneranda Sophia Ford-Glanton, MD
Organizational Affiliation
Saint Louis University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21420124
Citation
McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
Results Reference
result
PubMed Identifier
26068624
Citation
Roehrborn CG, Rukstalis DB, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rashid P. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. 2015 Jun;22(3):7772-82.
Results Reference
result
PubMed Identifier
25937539
Citation
Sonksen J, Barber NJ, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Montorsi F, Patterson JM, Fahrenkrug L, Schoenthaler M, Gratzke C. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015 Oct;68(4):643-52. doi: 10.1016/j.eururo.2015.04.024. Epub 2015 Apr 30.
Results Reference
result
PubMed Identifier
23370938
Citation
Pisco JM, Rio Tinto H, Campos Pinheiro L, Bilhim T, Duarte M, Fernandes L, Pereira J, Oliveira AG. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and mid-term follow-up. Eur Radiol. 2013 Sep;23(9):2561-72. doi: 10.1007/s00330-012-2714-9. Epub 2013 Jan 31. Erratum In: Eur Radiol. 2013 Sep;23(9):2573-4.
Results Reference
result
PubMed Identifier
24176946
Citation
Bagla S, Martin CP, van Breda A, Sheridan MJ, Sterling KM, Papadouris D, Rholl KS, Smirniotopoulos JB, van Breda A. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. J Vasc Interv Radiol. 2014 Jan;25(1):47-52. doi: 10.1016/j.jvir.2013.09.010. Epub 2013 Oct 28.
Results Reference
result
PubMed Identifier
26314640
Citation
Uflacker AB, Haskal ZJ. Internal Iliac Artery Embolization for Benign Prostatic Hyperplasia? First Read the Fine Print. J Vasc Interv Radiol. 2015 Sep;26(9):1311-2. doi: 10.1016/j.jvir.2015.06.024. No abstract available.
Results Reference
result
PubMed Identifier
27321890
Citation
Pisco JM, Bilhim T, Pinheiro LC, Fernandes L, Pereira J, Costa NV, Duarte M, Oliveira AG. Medium- and Long-Term Outcome of Prostate Artery Embolization for Patients with Benign Prostatic Hyperplasia: Results in 630 Patients. J Vasc Interv Radiol. 2016 Aug;27(8):1115-22. doi: 10.1016/j.jvir.2016.04.001. Epub 2016 Jun 16.
Results Reference
result
Learn more about this trial
Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men
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