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

NCT03043222 | Withdrawn FDA Device

• 1 other identifier: 27936
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Improvement in QOL

  Improvement in QOL score

  3,6,12 months

Secondary Outcomes (11)

• Number of patients with clinical adverse events

  1 day, 8 days and 1,3,6,12 months

• Post operative morbidity

  1 day, 8 days and 1 month

• Recovery experience

  1 day, 8 days and 1 month

• Improvement in symptoms of LUTS

  3,6,12 months

• Lack of change in sexual function

  3,6,12 months

Study Arms (2)

PAE-Prostate Arterial Embolization

EXPERIMENTAL

PAE-Prostate Arterial Embolization

Device: UroLift as artifical device for prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for prostate artery embolization

PUL- Prostatic urethral lift

ACTIVE COMPARATOR

PUL- Prostatic urethral lift

Device: UroLift as artifical device for prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for prostate artery embolization

Interventions

UroLift as artifical device for prostatic urethral lift. DEVICE

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.

Also known as: Prostatic urethral lift.

PAE-Prostate Arterial Embolization; PUL- Prostatic urethral lift

Embospheres Microspheres as embolic agents for prostate artery embolization DEVICE

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.

Also known as: Prostate artery embolization

PAE-Prostate Arterial Embolization; PUL- Prostatic urethral lift

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• 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.

  PMID: 21420124 RESULT

• 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.

  PMID: 26068624 RESULT

• 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.

  PMID: 25937539 RESULT

• 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.

  PMID: 23370938 RESULT

• 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.

  PMID: 24176946 RESULT

• 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.

  PMID: 26314640 RESULT

• 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.

  PMID: 27321890 RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Urinary Incontinence, Urge; Urinary Incontinence; Nocturia

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Keith Pereira, MD

  Saint Louis University Hospital

  PRINCIPAL INVESTIGATOR

• Beneranda Sophia Ford-Glanton, MD

  Saint Louis University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant professor, Interventional Radiology

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: March 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)