Treatment for Benign Prostatic Hyperplasia, a comparative study between dual pharmacological treatment (Tamsulosin and Finasteride) and a minimally invasive Prostatic Urethral Lift procedure (Urolift)

Phase 3

Recruiting

• Conditions: Prostate Hyperplasia

• Registration Number: RBR-1094jttz
• Lead Sponsor: niversidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-19
• Last Update Posted: 29 May 2023
• Study Completion: 2025-02-01

Recruitment & Eligibility

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the impact of Prostate Urethral Lift compared to Combined Pharmacological Therapy by improving the International Prostate Symptom Score Patients in both groups will have returns and results compared at 30 days, 90 days, 180 days and 1 year after starting the intervention. It is expected to find a drop in the international score of prostatic symptoms of around 6 points in the pharmacological therapy group and 8 to 11 points in the Prostatic Urethral Elevation group