Randomization of Botox for Stent Pain and Irritative Voiding Symptoms

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

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Irvine
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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 genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening

• Patients with concurrent or previously uninvestigated hematuria within 6 months prior to screening. -Patients with investigated hematuria may have entered the study if urological/renal pathology had been ruled out to the satisfaction of the investigator

• Patients with hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis Patients with a known allergy or sensitivity to any botulinum toxin preparation (including study medication preparation), anesthetics, or antibiotics used during the study

• Patients with any medical condition that may have put them at increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis