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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

PROFESSOR PIER FRANCESCO BASSI, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT01566292

First received: March 9, 2012

Last updated: March 27, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2012

Last Updated Date

March 27, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01566292 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

safety and tolerability of treatment [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: BOTOX

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

Other Name: Botulinum toxin type A

Study Arm (s)

Experimental: BOTOX

Intervention: Drug: BOTOX

Publications *

Maria G, Brisinda G, Civello IM, Bentivoglio AR, Sganga G, Albanese A. Relief by botulinum toxin of voiding dysfunction due to benign prostatic hyperplasia: results of a randomized, placebo-controlled study. Urology. 2003 Aug;62(2):259-64; discussion 264-5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01566292

Other Study ID Numbers ^ICMJE

268/08

Has Data Monitoring Committee

Yes

Responsible Party

PROFESSOR PIER FRANCESCO BASSI, Catholic University of the Sacred Heart

Study Sponsor ^ICMJE

Catholic University of the Sacred Heart

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

PierFrancesco Bassi, Professor

Catholic University of sacred Heart

Information Provided By

Catholic University of the Sacred Heart

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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