Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
NCT ID: NCT01566292
Last Updated: 2012-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
33 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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BOTOX
BOTOX
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Interventions
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BOTOX
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
80 Years
MALE
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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PROFESSOR PIER FRANCESCO BASSI
Prof
Principal Investigators
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PierFrancesco Bassi, Professor
Role: PRINCIPAL_INVESTIGATOR
Catholic University of sacred Heart
Locations
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Catholic University of Sacred Heart
Rome, , Italy
Countries
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References
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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. doi: 10.1016/s0090-4295(03)00477-1.
Other Identifiers
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268/08
Identifier Type: -
Identifier Source: org_study_id
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