MedTrace Logo

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

NCT01566292 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-03-29

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

BOTOX

Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • PierFrancesco Bassi, Professor · Catholic University of sacred Heart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566292 on ClinicalTrials.gov