Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• 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.

• 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.