Randomization of Botox for Stent Pain and Irritative Voiding Symptoms
Status:
Terminated
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
Summary
Botulinum toxin type A (Botox A) has shown great success in treating certain urologic
conditions. A recent study has documented that Botox injected around the ureteral orifice (or
place where the tube that connects the kidney to the bladder enters the bladder), during
placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the
kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced
by patients. This finding was quite remarkable as stents are commonly used in many Urologic
conditions, and these stents produce a remarkable degree of patient discomfort. Despite the
great improvement in pain reduction, the irritative voiding symptoms [frequent need to void,
urgency, burning with urination (dysuria) or nighttime voiding (nocturia)] were not
ameliorated by the Botox injections in the ureteral orifice. However, it has already been
well documented that in other clinical settings, administrations of Botox into the bladder
muscle, has been shown to reduce these irritative symptoms.
The objective of the study is to determine if pain and irritative lower urinary tract
symptoms related to ureteral stent placement will improve after the injection of Botox around
the ureteral orifice and in the bladder itself.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, Irvine
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA