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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566292
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Information provided by (Responsible Party):
PROFESSOR PIER FRANCESCO BASSI, Catholic University of the Sacred Heart

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
Benign Prostatic Hyperplasia (BPH) Benign Prostatic Enlargement (BPE) Drug: BOTOX Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: BOTOX Drug: BOTOX
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Other Name: Botulinum toxin type A

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. [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. safety and tolerability of treatment [ Time Frame: 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.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566292

Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Principal Investigator: PierFrancesco Bassi, Professor Catholic University of sacred Heart

Publications of Results:
Responsible Party: PROFESSOR PIER FRANCESCO BASSI, Prof, Catholic University of the Sacred Heart Identifier: NCT01566292     History of Changes
Other Study ID Numbers: 268/08
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents