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Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS

NCT01589263 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-10-05

Study results available
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Summary

Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life significantly, and are costly.

his Phase 2 clinical research trial is a double-blind, randomized, placebo-controlled, parallel-group study to compare the treatment effects of onaBoNT-A 200 U versus 0.4 mg per day of oral tamsulosin in male Veterans diagnosed with moderate to severe LUTS \[American Urologic Association Symptom Score (AUASS) equal to or greater than 8\] associated with BPH. A total of 74 volunteers will be recruited to participate in this clinical trial. Volunteers will include only males who are greater than 50 years of age and diagnosed with LUTS associated with BPH. They are Veterans who visit the Michael E. DeBakey Veterans Affairs Medical Center - Houston (MEDVAMC). There are no eligibility restrictions as to race or ethnicity.

Conditions

  • Benign Prostatic Hyperplasia
  • Lower Urinary Track Symptoms

Interventions

DRUG

onaBoNT-A + placebo

200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo

DRUG

Tamsulosin + placebo

0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Christopher P Smith, MD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-01
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589263 on ClinicalTrials.gov