OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christopher Patrick Smith
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; Mandelic Acids; onabotulinumtoxinA; Oxybutynin

Criteria

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.