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

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

BOTOX

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Catholic University of Sacred Heart

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BOTOX

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01566292

First Posted

March 9, 2012

Last Updated

March 27, 2012

Sponsor

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT01566292

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BOTOX

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BOTOX

Other Intervention Name(s)

Botulinum toxin type A

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

safety and tolerability of treatment

Description

Time Frame

3 month

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

PierFrancesco Bassi, Professor

Organizational Affiliation

Catholic University of sacred Heart

Official's Role

Principal Investigator

Facility Information:

Facility Name

Catholic University of Sacred Heart

City

Rome

ZIP/Postal Code

00168

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

12893330

Citation

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.

Results Reference

result

Learn more about this trial

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

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