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OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050114
Recruitment Status : Unknown
Verified August 2016 by Christopher Patrick Smith, Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : January 15, 2010
Last Update Posted : August 30, 2016
Information provided by (Responsible Party):
Christopher Patrick Smith, Baylor College of Medicine

Brief Summary:

Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine).

OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold.

This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases.

Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day.

The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: onaBoNT-A Drug: Oxybutynin ER Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized Study of the Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT-A) Versus Oral Oxybutynin in Spinal Cord Injured Patients With Neurogenic Detrusor Overactivity (Protocol Number 11-09-10-04)
Study Start Date : August 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
ARM 1: onaBoNT-A injection + placebo
onaBoNT-A 200 U (treatment 1)/ onaBoNT-A 200 U (treatment 2)/ onaBoNT-A 200 U (treatment 3) and placebo oral capsule daily
Drug: onaBoNT-A

onaBoNT-A will be the active formulation. Each vial of onaBoNT-A Purified Neurotoxin Complex, Formulation No. 9060X, contains: 100 units (U) of Clostridium botulinum toxin type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. One U corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. A 0.9% sterile saline (without preservative) for injection will be used as diluent for onaBoNT-A.

Each treatment session will be administered as 20 injections each of 1 mL (10U/ml), evenly distributed into the bladder.

Other Names:
  • onabotulinumtoxinA
  • BOTOX(R)

ARM 2: Placebo injection + oxybutynin ER
Placebo injection (treatment 1)/ onaBoNT-A 200 U (treatment 2)/ onaBoNT-A 200 U (treatment 3) and oxybutynin ER 10 mg capsule daily
Drug: Oxybutynin ER
Oxybutynin ER in a 10 mg capsule will be taken twice a day for the course of the study.
Other Names:
  • Ditropan XL
  • Urotrol
  • Oxytrol

Primary Outcome Measures :
  1. Primary endpoint [ Time Frame: 12 weeks ]
    The primary endpoint is the reduction in mean weekly incontinent episodes in the onaBoNT-A treated group compared to the oxybutynin treated group at 12 weeks.

Secondary Outcome Measures :
  1. The utility of urinary inflammatory markers as statistically significant predictors of treatment response. [ Time Frame: 30 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female, aged 18 to 80 years old, weighing 110 pounds or more.
  • urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury
  • must have a stable neurological injury occurring at least 6 months or more.
  • has detrusor overactivity demonstrated during the screening period or within 1 year of screening.
  • has a negative pregnancy result if female and of childbearing potential.

The following criteria are also required for entry into the study at Randomization/Day 1:

  • experiences at least 14 episodes or more of urinary incontinence per week with no more than 2 incontinent-free days.
  • currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted).
  • Volunteers with a negative urine culture result must take an antibiotic medication for 3 days immediately prior to Randomization/Day 1 and agree to continue antibiotic medication for at least 3 days following treatment. Volunteers with a positive urine culture result indicating urinary tract infection (UTI), must take an antibiotic to which the identified organism is sensitive for at least 3 days immediately prior to Randomization/Day 1, on Randomization/Day 1, and continue for 3 days following the procedure (or longer as needed).

Exclusion Criteria:

  • has history or evidence of any pelvic or urological abnormalities including but not limited to the following:

    1. elevated serum creatinine more than 2 times the upper limit of normal (reference range)
    2. current or history of hematuria, 1) if the hematuria is determined to be a pathologic condition or 2) is uninvestigated
    3. interstitial cystitis in the opinion of the investigator bladder stones within 6 months of screening
    4. surgery or bladder disease other than detrusor overactivity that may impact bladder function with the exception of surgeries for bladder stones (more than 6 months) and stress incontinence, uterine prolapse, rectocele, or cystocele (more than1year) from screening.
  • has had previous or current botulinum toxin therapy within 9 months.
  • has been immunized for any botulinum toxin serotype.
  • discontinued anticholinergic medication for overactive bladder less than 14 days prior to Randomization/Day 1.
  • has a history or current diagnosis of bladder cancer.
  • male with previous or current diagnosis of prostate cancer or has a Prostate Specific Antigen (PSA) level greater than 10.0 ng/mL.
  • has 24 hour total volume voided more than 3000 mL of urine
  • has a post void residual volume above 200 mL.
  • has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening.
  • uses any anti-platelet or anticoagulant therapy or is using medications with anticoagulative effects within 3 days prior to treatment.
  • has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diatheses.
  • has had concurrent treatment or treatment within 6 months of Randomization/Day 1 with capsaicin or resiniferatoxin.
  • currently using or plans to use an implanted or non-implantable electrostimulation/ neuromodulation device for treatment of overactive bladder.
  • has a known allergy or sensitivity to any components of the study medication, anesthetics or antibiotics or any other products associated with the treatment and general study procedures.
  • has any medical condition that may put the volunteer at increased risk with exposure to onaBoNT-A including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis.
  • female and pregnant, nursing or planning a pregnancy during the study, or of childbearing potential and unable or unwilling to use a reliable form of contraception during the study.
  • currently or has previously participated in another therapeutic drug or device study within 30 days of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050114

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Contact: Sebrina Tello 713-798-8106

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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sebrina Tello    713-798-8106   
TIRR-Memorial Hermann Not yet recruiting
Houston, Texas, United States, 77030
Contact: Sebrina Tello    713-798-8106   
Sub-Investigator: John E. Bertini, Jr., MD         
Sponsors and Collaborators
Christopher Patrick Smith
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Study Director: Christopher P. Smith, MD Baylor College of Medicine
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Responsible Party: Christopher Patrick Smith, Associate Professor, Baylor College of Medicine Identifier: NCT01050114    
Other Study ID Numbers: 11-09-10-04 (BCM H-26296)
H-26296 ( Other Identifier: Baylor College of Medicine )
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published in aggregate.
Keywords provided by Christopher Patrick Smith, Baylor College of Medicine:
Botulinum Toxin
Overactive Bladder
Spinal Cord Injury
Urinary Incontinence
Nerve Growth Factor
Urine Biomarkers
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Urological Agents