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.|
|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|
|Actual 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01566292
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|
|Principal Investigator:||PierFrancesco Bassi, Professor||Catholic University of sacred Heart|