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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01566292

Enrollment

Registered

2012-03-29

Start date

2009-09-30

Completion date

Unknown

Last updated

2012-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGBOTOX

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026