Clinical Trial: Randomization of Botox for Stent Pain and Irritative Voiding Symptoms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: University of California, Irvine

Current Primary Outcome: 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) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]
  • Post-surgical analgesic requirements [ Time Frame: post-operative to follow up day (2 weeks) ]

    Post-surgical analgesic requirements: Oral opiates/-patients to keep written record (number/duration

    -# of days)



Original Secondary Outcome: Same as current

Information By: University of California, Irvine

Dates:
Date Received: February 26, 2014
Date Started: February 2014
Date Completion: February 2017
Last Updated: November 3, 2016
Last Verified: November 2016