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

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH); Benign Prostatic Enlargement (BPE)
• Interventions: Drug: BOTOX

• Registration Number: NCT01566292
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-09
• Status Verified: 2012-03
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-27
• Last Update Submitted: 2012-03-27
• Study First Posted: 2012-03-29
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BOTOX	BOTOX	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of treatment	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.

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy