Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy

Benign Prostatic Hyperplasia (BPH) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566292
• Other study ID #: 268/08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 9, 2012
• Last updated: March 27, 2012
• Start date: September 2009

Study information

• Verified date: March 2012
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Benign Prostatic Enlargement (BPE)
• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• BOTOX
Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 month	No
Secondary	safety and tolerability of treatment	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.	3 month	Yes