Status:
WITHDRAWN
Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Benign Prostatic Hyperplasia (BPH)
Prostate Cancer
Eligibility:
MALE
51+ years
Phase:
NA
Brief Summary
The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®, in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of urinary obstructive ...
Detailed Description
Prostatic Urethral Lift (PUL)/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH) (also called prostate gland enlargement). This stu...
Eligibility Criteria
Inclusion
- International Prostate Symptom Score ≥ 12.
- Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
- Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).
Exclusion
- Obstructive median lobe of the prostate.
- Active urinary tract infection.
- Neurogenic non-obstructive voiding dysfunction.
- Obstructive symptoms secondary to prostate cancer (via cystoscopy).
- Patients with prior Transurethral resection of the prostate (TURP).
- Patients with prior history of urethral stricture.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03817216
Start Date
December 1 2019
End Date
March 30 2023
Last Update
March 12 2020
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