Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding
Taiwan70 participantsStarted 2012-10
Plain-language summary
This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients with dysfunctional voiding. The results of this study can provide further information for patient selection and therapeutic duration.
Who can participate
Age range20 Years ā 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults with age of 20 years old or above.
* Free of active urinary tract infection.
* Free of bladder outlet obstruction on enrollment.
* Patients should have severe dysuria or urinary retention, large residual urine and have been treated with medication or other therapeutic modality for over 3 months.
Exclusion Criteria:
* 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 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.
* 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.
* Written informed consent has been obtained.
What they're measuring
1
Net change of Patient Perception of Bladder Condition (PPBC)