Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
|ClinicalTrials.gov Identifier: NCT01566292|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Primary Completion Date :||September 2010|
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Other Name: Botulinum toxin type A
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566292
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|
|Principal Investigator:||PierFrancesco Bassi, Professor||Catholic University of sacred Heart|