Prostate Hyperplasia
Conditions
Interventions
This study is a prospective, randomized trial conducted at a single center in Brazil. A number of 120 patients with symptomatic BPH will be randomized 1:1 between combined pharmacological therapy (CPT
D02.065.884.863
D04.210.500.054.079.500
Sponsors
Universidade de São Paulo
Teleflex Inc
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Peak flow assessed by uroflowmetry 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 an improvement in urinary flow of around 2.5 ml/s in the pharmacological therapy group and 3.5 ml/s in the prostatic urethral elevation group;To evaluate Ejaculatory function assessed by the Male Sexual Health Questionnaire and Ejaculatory Dysfunction (MSHQ-EjD short form), 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 ejaculatory disorder around 17% in the pharmacological therapy group and 0 to 2% in the prostatic urethral elevation group;To evaluate quality of life in relation to urinary tract symptoms assessed by the Benign Prostatic Hyperplasia Impact Index (BPHII), 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 Benign Prostatic Hyperplasia Impact Index (BPHII) less than 4 in both groups;To evaluate Sexual function assessed by the International Index of Erectile Function (IIEF-5), 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 maintenance of the International Index of Erectile Function (IIEF-5) in both groups;To evaluate urinary incontinence assessed by the Incontinence Severity Index (ISI), 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 expect to find maintenance of the Incontinence Severity Index (ISI) in both groups;To evaluate the urodynamic effects, patients of both groups will be compared with pre-intervention and after 1 year exams. It is expected to find an improvement in urinary flow at the expense of lower intravesical | — |
Countries
Brazil
Contacts
Public ContactOswaldo Neto
Universidade de São Paulo
Outcome results
None listed