Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urge urinary incontinence (UUI) that may affect the patients' quality of life. Current medical treatments are usually unsuccessful in completely eradicating urgency sensation. Intra-detrusor injection of botulinum toxin A (BoNT-A) modulates the release of neurotransmitters from sensory nerve endings and effectively modulates the inflammatory process mediated by nociceptive afferent nerve dysfunction. Satisfactory clinical results were achieved with intravesical BoNT-A injection, which increased bladder capacity and decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity (NDO, IDO). Excellent results were achieved with injection of either 100 U or 200 U of BoNT-A. Episodes of frequency, urgency, and UUI were reduced, maximal cystometric capacity increased, maximal detrusor pressure (Pdet) decreased, and the quality of life index also improved significantly. However, post void residual (PVR) volume increased significantly and some patients required clean intermittent catheterization (CIC) to evacuate the PVR. Dose-related adverse events (AE) increased with increasing dose of BoNT-A. Therefore, adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help to maintain success rates.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• The inclusion criteria were patients of either gender, aged 20 years or more, with urodynamic DO and at least one episode of urgency (urgency severity scale, USS≥2) or UUI per day as recorded in the 3-day voiding diary. Patients with neurogenic bladder, urodynamically confirmed bladder outlet obstruction, prior pelvic surgery, anti-incontinence surgery or urinary tract infection (UTI, white blood cell (WBC) >10/high power field (HPF) in urinalysis) were excluded. Informed consent was obtained from all patients before randomization. This study should be approved by the Institution Review Board and Ethics Committee of the hospital.

Exclusion Criteria:

• Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms

• Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up

• Patients with bladder outlet obstruction on enrollment

• Patients with postvoid residual > 150ml

• Patients with uncontrolled confirmed diagnosis of acute urinary tract infection

• Patients have laboratory abnormalities at screening including:

• Alanine aminotransferase (ALT)> 3 x upper limit of normal range

• Aspartate aminotransferase (AST)> 3 x upper limit of normal range

• Patients have abnormal serum creatinine level > 2 x upper limit of normal range

• Patients with any contraindication to be urethral catheterization during treatment

• Female patients who is pregnant, lactating, or with child-bearing potential without contraception.

• Myasthenia gravis, Eaton Lambert syndrome.

• Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial Patients participated investigational drug trial within 1 month before entering this study