Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy

Catholic University of the Sacred Heart33 enrolled

Overview

The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH). Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Benign Prostatic Hyperplasia (BPH)Benign Prostatic Enlargement (BPE)

Interventions

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate-to-severe LUTS as determined by the International Prostate Symptom Score * Mean peak urinary flow rate of no more than 15 mL/s with a voided volume of at least 150 mL, or postvoid residual urine volume (PVR) of more than 100 ml and urodynamic parameters indicative of bladder outlet obstruction (BOO) according to International Continence Society Exclusion Criteria: * Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study.

Outcomes

Primary Outcomes

evaluation of symptomatic improvement after treatment as measured by the IPSS score. A successful outcome was defined as a reduction of IPSS score of > 50% from baseline.

Time frame: 3 month

Secondary Outcomes

safety and tolerability of treatment

Quality of life improvement as measured by QoL score, changes in prostate volume, total PSA levels, maximal flow at uroflowmetry, post-void residual urine,maximal cystometric capacity, Bladder Outlet Obstruction Index, sexual modifications evaluated by International Index of Erectile Function.