RBR-1094jttz
Recruiting
Phase 3
Prospective, randomized study of Prostatic Urethral Lift versus Combined Pharmacological Therapy for men with LUTS-BPH - CombLIFT Combined pharmacological therapy vs Lift of prostatic urethral
niversidade de São Paulo0 sitesMay 19, 2023
ConditionsProstate Hyperplasia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostate Hyperplasia
- Sponsor
- niversidade de São Paulo
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men aged \> 50 years, with symptomatic prostate hyperplasia and willing to undergo treatment; International Prostate Symptom Score IPSS \= 13; Peak urine flow rate \= 12ml/s in a urine volume \= 125ml; Prostate volume \= 40 cc and \= 100 cc and prostatic length \= 40 mm and \= 100 mm assessed by transabdominal prostate ultrasound
Exclusion Criteria
- •Current urinary retention; Post voiding residue \> 250ml; Prostate protrusion index (PPI) \= 1cm on transabdominal prostate ultrasound;. Active urinary tract infection at the time of treatment; Procedure for treating previous BPH; Urethral conditions that may prevent insertion and release of the device into the bladder (urethral stenosis, meatus stenosis, bladder neck contracture); Previous pelvic surgery or irradiation; History of neurogenic or atonic bladder; Urinary incontinence; Prostate biopsy within the last 6 weeks; Estimated life expectancy of less than 1 year;;History of prostate or bladder cancer;; PSA \> 10ng/ml unless prostate biopsy is negative for cancer; Current macroscopic hematuria; Serum creatinine \> 1\.8mg/dl or upper tract disease that compromises renal function; Known coagulopathies or use of anticoagulants or antiplatelet agents other than aspirin \= 10 mg (unless antiplatelet agents are suspended at least 3 days before the procedure); Use within 4 months of baseline assessment: estrogen, any androgen\-suppressing medication, or anabolic steroids.Within 3 months of baseline assessment: 5\-alpha\-reductase inhibitor; Within 2 weeks of the initial assessment; Alpha\-blockers, androgens, gonadotropin releasers, hormone analogues, anticholinergics or cholinergic medication; Medications with phenylephrine, pseudoephedrine or imipramine; Within 6 months of baseline: combination therapy with 5\-alpha\-reductase inhibitor and alpha\-blockers; Within 1 week of baseline, unless documented stable dose for \= 6 months: beta\-blockers, antidepressants, anticonvulsants, and antispasmodics;Cystolithiasis in the last 3 months;History of prostatitis requiring treatment (antibiotics) in the last year; Other comorbidities that may impact the outcome of the study, such as: severe cardiac arrhythmias not controlled by medication or a pacemaker, congestive heart failure NYHA III or IV, history of uncontrolled diabetes mellitus, significant respiratory disease in which hospitalization may if necessary, known immunosuppression (AIDS, post\-transplant, in chemotherapy); Unable or unwilling to complete all required questionnaires and follow\-up assessments; Unable or unwilling to sign the informed consent form; Currently enrolled in any other experimental clinical research trials that have not completed the primary endpoint
Outcomes
Primary Outcomes
Not specified
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