Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy: a Randomised, Double-blind, Controlled Trial Using Subjective and Objective Outcomes

Catholic University of the Sacred Heart1 site in 1 country33 target enrollmentSeptember 2009

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

InterventionsBOTOX

DrugsBOTOX

Overview

Phase: Phase 2
Intervention: BOTOX
Conditions: Benign Prostatic Hyperplasia (BPH)
Sponsor: Catholic University of the Sacred Heart
Enrollment: 33
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

September 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Catholic University of the Sacred Heart

Responsible Party

Principal Investigator

PROFESSOR PIER FRANCESCO BASSI

Prof

Catholic University of the Sacred Heart

Eligibility Criteria

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.

Arms & Interventions

BOTOX

Intervention: BOTOX

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