Botulinum Toxins, Type A Clinical Trial
Official title:
Comparative Study of Safety and Efficacy Between 100 U Suburothelial Injection and 50 U Suburothelial Plus 50 U Urethral Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility
Verified date | February 2017 |
Source | Buddhist Tzu Chi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Buddhist Tzu Chi General Hospital | Hualien |
Lead Sponsor | Collaborator |
---|---|
Buddhist Tzu Chi General Hospital |
Taiwan,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Net change of the Patients Perception of Bladder Condition (PPBC) | Net change of the Patients Perception of Bladder Condition (PPBC, scored from 1 to 6) from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, urinary tract infection (UTI), urinary retention) Systemic adverse events. Safety: Systemic adverse events |
Baseline and 3 months | |
Secondary | Net change of the International Prostate Symptom Score (IPSS) | Net change of the following parameters from baseline to 3 month after the treatment day: lower urinary tract symptom score (including empty and storage IPSS) | Baseline and 3 months | |
Secondary | Net change of the bladder capacity | Efficacy: Net change of the following parameters from baseline to 3 month after the treatment day: bladder capacity Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the voiding frequency at daytime | Efficacy: Net change of the following parameters from baseline to 3 month after the treatment day: voiding frequency at daytime. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the voiding frequency at night time | Efficacy: Net change of the following parameters from baseline to 3 month after the treatment day: voiding frequency at night time. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of voiding urgency severity score | Efficacy: Net change of the following parameters from baseline to 3 month after the treatment day: urgency severity score Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the first sensation of bladder filling | Efficacy: Net change of the urodynamic parameters: first sensation of bladder filling from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the urge sensation | Efficacy: Net change of the urodynamic parameters: urge sensation from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the presence of detrusor overactivity | Efficacy: Net change of the urodynamic parameters: presence of detrusor overactivity from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the cystometric bladder capacity | Efficacy: Net change of the urodynamic parameters: cystometric bladder capacity from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the first sensation of detrusor pressure | Efficacy: Net change of the urodynamic parameters: detrusor pressure from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the first sensation of bladder compliance | Efficacy: Net change of the urodynamic parameters: bladder compliance from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the maximum flow rate | Efficacy: Net change of the urodynamic parameters: maximum flow rate from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the first sensation of voided volume | Efficacy: Net change of the urodynamic parameters: voided volume from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months | |
Secondary | Net change of the postvoid residual volume | Efficacy: Net change of the urodynamic parameters: postvoid residual volume from baseline to 3 months after the treatment day. Safety: Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events. |
Baseline and 3 months |
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