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

Catholic University of the Sacred Heart

Status and phase

Completed

Phase 3

Phase 2

Conditions

Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Enlargement (BPE)

Treatments

Drug: BOTOX

Study type

Interventional

Funder types

Other

Identifiers

NCT01566292

268/08

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.