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

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Completed
CT.gov ID
NCT01566292
Collaborator
(none)
33
Enrollment
1
Location
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: BOTOX

Drug: BOTOX
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Other Names:
  • Botulinum toxin type A

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [3 month]

    Secondary Outcome Measures

    1. safety and tolerability of treatment [3 month]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catholic University of Sacred Heart Rome Italy 00168

    Sponsors and Collaborators

    • Catholic University of the Sacred Heart

    Investigators

    • Principal Investigator: PierFrancesco Bassi, Professor, Catholic University of sacred Heart

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PROFESSOR PIER FRANCESCO BASSI, Prof, Catholic University of the Sacred Heart
    ClinicalTrials.gov Identifier:
    NCT01566292
    Other Study ID Numbers:
    • 268/08
    First Posted:
    Mar 29, 2012
    Last Update Posted:
    Mar 29, 2012
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Mar 29, 2012