Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
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.
Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Enlargement (BPE)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- 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 ]
- 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.
|Study Start Date:||September 2009|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Other Name: Botulinum toxin type A
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566292
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|
|Principal Investigator:||PierFrancesco Bassi, Professor||Catholic University of sacred Heart|