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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

March 9, 2012
March 27, 2012
September 2009
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01566292 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Benign Prostatic Hyperplasia (BPH)
  • Benign Prostatic Enlargement (BPE)
Drug: BOTOX
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Other Name: Botulinum toxin type A
Experimental: BOTOX
Intervention: Drug: BOTOX
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.
 
Completed
33
Not Provided
September 2010   (final data collection date for primary outcome measure)

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.
Male
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01566292
268/08
Yes
PROFESSOR PIER FRANCESCO BASSI, Catholic University of the Sacred Heart
Catholic University of the Sacred Heart
Not Provided
Principal Investigator: PierFrancesco Bassi, Professor Catholic University of sacred Heart
Catholic University of the Sacred Heart
March 2012

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