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

Not Applicable

Withdrawn

• Conditions: Lower Urinary Tract Symptoms; Incontinence, Urinary; Nocturia; Benign Prostatic Hyperplasia; Urinary Frequency/Urgency; Urinary Incontinence, Urge
• Interventions: Device: UroLift as artifical device for prostatic urethral lift.; Device: Embospheres Microspheres as embolic agents for prostate artery embolization

• Registration Number: NCT03043222
• Lead Sponsor: St. Louis University

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.

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Status Verified: 2018-03
• Study Start: 2018-03-01
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20
• Primary Completion: 2019-04-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

  1. Active urinary tract infections, prostatitis, or interstitial cystitis.

  2. 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

  3. Significant median lobe enlargement.

  4. Large prostates, volume >80 g.

  5. 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.)

  6. 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

  7. Urethral conditions that may prevent insertion of a rigid 20F cystoscope

  8. Current urinary retention.

  9. Acontractile detrusor.

  10. Current gross hematuria

  11. Known upper tract renal disease

  12. Cystolithiasis

  13. ASA > 3 or severe medical debilitating condition

  14. History of pelvic irradiation or radical pelvic surgery

  15. Known allergy to nickel.

      PAE

  16. Active urinary tract infections, prostatitis, or interstitial cystitis.

  17. 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

  18. Unable to have CT angio of the prostate imaging

  19. 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.)

  20. 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

  21. Acontractile detrusor.

  22. Known upper tract renal disease

  23. Cystolithiasis

  24. 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

  25. ASA > 3 or severe medical debilitating condition

  26. Baseline serum creatinine level > 1.8 mg/dl

  27. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease

  28. History of pelvic irradiation or radical pelvic surgery

  29. Allergy to iodinated contrast agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAE-Prostate Arterial Embolization	UroLift as artifical device for prostatic urethral lift.	PAE-Prostate Arterial Embolization
PAE-Prostate Arterial Embolization	Embospheres Microspheres as embolic agents for prostate artery embolization	PAE-Prostate Arterial Embolization
PUL- Prostatic urethral lift	UroLift as artifical device for prostatic urethral lift.	PUL- Prostatic urethral lift
PUL- Prostatic urethral lift	Embospheres Microspheres as embolic agents for prostate artery embolization	PUL- Prostatic urethral lift

Primary Outcome Measures

Name	Time	Method
Improvement in QOL	3,6,12 months	Improvement in QOL score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States