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

NCT01589263 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CLIN-023-11F115,132H-27457
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms; BPH; LUTS

Outcome Measures

Primary Outcomes (1)

• American Urologic Association Symptom Score (AUASS)

  AUA Symptom Score on a scale of 0 to 35, 35 is the worse outcome and 0 is the best outcome.

  3 months

Study Arms (2)

ARM 1: onaBoNT-A + placebo

ACTIVE COMPARATOR

onaBoNT-A 200 U prostate injection and placebo oral capsule daily

Drug: onaBoNT-A + placebo; Drug: Tamsulosin + placebo

ARM 2: Saline + Tamsulosin

ACTIVE COMPARATOR

Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily.

Drug: onaBoNT-A + placebo; Drug: Tamsulosin + placebo

Interventions

onaBoNT-A + placebo DRUG

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

Also known as: Botox

ARM 1: onaBoNT-A + placebo; ARM 2: Saline + Tamsulosin

Tamsulosin + placebo DRUG

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

Also known as: Flomax

ARM 1: onaBoNT-A + placebo; ARM 2: Saline + Tamsulosin

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Males at least 50 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males at least 50 years of age
• American Urological Association Symptom Score greater than 8
• Voided volume greater than 125 ml
• Maximum urinary flowrate less than 15 ml/sec.
• Must agree to all procedures and willfully consented

You may not qualify if:

• Any prior surgical intervention or use of 5-alpha-reductase medical intervention for BPH
• Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH)
• Previous exposure to onabotulinumtoxinA
• Overactive bladder without obstructive symptoms (i.e. decrease in force of stream, hesitancy, intermittency, post-void dribbling)
• Active urinary tract disease or biopsy of the prostate within the past 6 weeks;
• Two documented urinary tract infections of any type in the past year (UTI defined as greater than 100,000 colonies per ml urine from midstream clean catch or catheterized specimen)
• Uncontrolled diabetes
• History of bladder calculi (stones)
• Penile prosthesis or artificial urinary sphincter \[placement\]
• Documented bacterial or acute prostatitis within the past year
• Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months
• Known primary neurologic conditions such as multiple sclerosis, myasthenia gravis or Parkinson's disease, or other neurological diseases known to affect bladder function
• History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or bladder neck obstruction
• Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years)
• Any serious medical condition that is likely to impede successful completion of the study, such as certain mental disorders, hypersensitivity to onabotulinumtoxinA or anesthetics used in the study, syncope

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Crawford ED, Hirst K, Kusek JW, Donnell RF, Kaplan SA, McVary KT, Mynderse LA, Roehrborn CG, Smith CP, Bruskewitz R. Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol. 2011 Sep;186(3):965-70. doi: 10.1016/j.juro.2011.04.062. Epub 2011 Jul 24.

  PMID: 21791356 RESULT

• Smith CP, Chancellor MB. Emerging role of botulinum toxin in the management of voiding dysfunction. J Urol. 2004 Jun;171(6 Pt 1):2128-37. doi: 10.1097/01.ju.0000127725.48479.89.

  PMID: 15126771 RESULT

• Chancellor MB, Fowler CJ, Apostolidis A, de Groat WC, Smith CP, Somogyi GT, Aoki KR. Drug Insight: biological effects of botulinum toxin A in the lower urinary tract. Nat Clin Pract Urol. 2008 Jun;5(6):319-28. doi: 10.1038/ncpuro1124. Epub 2008 May 6.

  PMID: 18461049 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

onabotulinum toxin A; Botulinum Toxins, Type A; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Christopher Smith
• Organization: Baylor College of Medicine

cps@bcm.edu

713-798-4001

Study Officials

• Christopher P Smith, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 1, 2012
• Study Start: June 1, 2012
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 5, 2021
• Results First Posted: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)