Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study is to evaluate and compare the efficacy and safety between 100 U of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A suburothelial injections and 50 U urethral injection for the treatment of detrusor overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents

• 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:

• Adults with age of 20 years old or above

• Patients with symptoms of urgency frequency and/or urge incontinence and urodynamically proven DHIC (defined by the ICS recommendation as: spontaneous detrusor contraction occurring during bladder filling phase or occurring before uninhibited detrusor contraction voiding at bladder capacity of less than 350ml in the urodynamic study, and has postvoid residual of more than 100ml but less than 250ml)

• Free of active urinary tract infection

• Free of bladder outlet obstruction on enrollment

• Free of overt neurogenic bladder dysfunction

• Having been treated with antimuscarinic agents for at least 1 months without effect or with intolerable adverse effects

• Patient or his/her legally acceptable representative has signed the written informed consent form

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 > 250ml

• Patients with uncontrolled confirmed diagnosis of acute urinary tract infection

• Patients have laboratory abnormalities at screening including:

ALT> 3 x upper limit of normal range 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

• Patients with any other serious disease considered by the investigator not in the condition to enter the trial

• Patients participated investigational drug trial within 1 month before entering this study