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CompletedNCT01566292Updated Mar 29, 2012

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

A Phase 2/3 interventional study of BOTOX in Benign Prostatic Hyperplasia (BPH) and Benign Prostatic Enlargement (BPE), sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-29.

Sponsored by Catholic University of the Sacred Heart · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Benign Prostatic Hyperplasia (BPH)
  • Benign Prostatic Enlargement (BPE)
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 33 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    BOTOX

    Drug: BOTOX

Interventions

  • DrugBOTOX

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

    Also known as: Botulinum toxin type A

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    Time frame: 3 month

07

Study locations

1 site
  • Catholic University of Sacred Heart
    Rome, 00168, Italy
08

References and documents

Publications

  • 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. PubMed 12893330 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01566292
Lead sponsor
Catholic University of the Sacred Heart
Responsible party
PROFESSOR PIER FRANCESCO BASSI (Prof, Catholic University of the Sacred Heart) — Principal investigator
First posted
Mar 29, 2012
Start date
Sep 2009
Primary completion
Sep 2010
Last update
Mar 29, 2012

Study contacts

PierFrancesco Bassi, Professor
principal investigator · Catholic University of sacred Heart

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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