Randomization of Botox for Stent Pain and Irritative Voiding Symptoms (NCT02078895) | Clinical Trial Compass
TerminatedPhase 3
Randomization of Botox for Stent Pain and Irritative Voiding Symptoms
Stopped: The study was terminated due to low enrollment
United States15 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients requiring unilateral ureteral stent insertion
* Age \> 18
* Renal/ureteral stones (single or multiple)
* Ureteral strictures
* Surveillance ureterscopy
* Willing and able to consent
* Willing and able to complete study questionnaires/diaries
* Willing to use CIC to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator
Exclusion Criteria:
* History of malignancy
* Patients on medical therapy for benign prostatic hyperplasia (alpha blocker and/or 5alpha reductase inhibitor)
* Patients taking muscarinic-receptor antagonists (Ex. detrol, ditropan etc.)
* Patients who have an interstim sacral neuromodulator
* History of urinary retention
* Neurogenic or non-neurogenic detrusor overactivity
* Pregnancy
* Solitary kidney
* Insulin dependent Diabetes Mellitus (Uncontrolled Diabetes (HbA1c \> 8))
* Neuropathy
* History of transplant kidney
* History of narcotic abuse or chronic pain
* Anatomic bladder/ureteral abnormality
* Previous cystectomy/urinary diversion
* Conditions necessitating bilateral ureteral stents
* History of Interstitial cystitis
* Patients with a post-void residual volume of \> 100ml
* Patients with history of urinary retention
* Patients with active urinary tract infection
* Patients with history of chronic urinary tract infections
* Patients with concomitant use of any botulinum toxin within 3 months or any urological use of botulinum toxin in the past
* Patients with active ge…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Lower Urinary Tract Discomfort between pre-operative visit date and the stent removal date and two week follow up.
Timeframe: 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)