Randomization of Botox for Stent Pain and Irritative Voiding Symptoms
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Evaluation of Peri-Ureteral and Intradetrusor Injection of Botulinum Toxin Type A for the Treatment of Ureteral Stent Related Pain and Irritative Voiding Symptoms|
- Change in Lower Urinary Tract Discomfort between pre-operative visit date and the stent removal date and two week follow up. [ Time Frame: At pre-operative visit (average of 7 days before stent placement), stent removal date (3-9 days after stent placement), and 2 week follow up (2 weeks after stent placement) ] [ Designated as safety issue: No ]Lower urinary tract symptoms (frequency, urgency, nocturia, dysuria) - Ureteral Stent Symptom Questionnaire (USSQ). The USSQ has different sections that pertain to different domains of a patient's life. Therefore, a total score from each section will be measured individually as described by Joshi et al (15). The different domains of the USSQ include urinary symptoms, body pain, general health, work performance, sexual matters. The total scores from each of these sections will be compared individually. In addition, the total score for the entire questionnaire will also be assessed.
- Post-operative pain - visual analog scale (VAS). [ Time Frame: At pre-operative visit (average of 7 days before stent placement), stent removal date (3-9 days after stent placement), and 2 week follow up (2 weeks after stent placement) ] [ Designated as safety issue: No ]
- Post-surgical analgesic requirements [ Time Frame: post-operative to follow up day (2 weeks) ] [ Designated as safety issue: No ]
Post-surgical analgesic requirements: Oral opiates/-patients to keep written record (number/duration
-# of days)
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
The experimental group will include ureteral stent placement with three peri-ureteral injections of Botox A and fourteen site-specific intradetrusor injections of Botox A.
Peri-Ureteral and Intradetrusor Injection of Botulinum Toxin Type A
Other Name: Botulinum Toxin Type A
No Intervention: Control
The control group will involve a ureteral stent placement with no injection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02078895
|Contact: Jaime Landman, MDfirstname.lastname@example.org|
|Contact: Victor Huyhn, BSemail@example.com|
|United States, California|
|University of California, Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Victor Huynh, BS 714-456-8176 firstname.lastname@example.org|
|Principal Investigator: Jaime Landman, MD|
|Sub-Investigator: Gamal Ghoniem, MD|
|Principal Investigator:||Jaime Landman, MD||University of California, Irvine Department of Urology|