Randomization of Botox for Stent Pain and Irritative Voiding Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02078895
Recruitment Status : Terminated (The study was terminated due to low enrollment)
First Posted : March 5, 2014
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
Jaime Landman, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Discomfort Stent Pain Drug: Botox Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : February 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Botox
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.
Drug: Botox
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Post-operative pain [ 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-operative pain - visual analog scale (VAS).

  2. 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)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02078895

United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Jaime Landman, MD University of California, Irvine Department of Urology


Responsible Party: Jaime Landman, Department of Urology Chair, University of California, Irvine Identifier: NCT02078895     History of Changes
Other Study ID Numbers: 2013-9702
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jaime Landman, University of California, Irvine:
Lower Urinary tract discomfort , ureteral stent pain

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents