Randomization of Botox for Stent Pain and Irritative Voiding Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Jaime Landman, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02078895
First received: February 26, 2014
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Lower Urinary Tract Discomfort
Stent Pain
Drug: Botox
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)



Estimated Enrollment: 80
Study Start Date: February 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078895

Contacts
Contact: Jaime Landman, MD 714-456-3330 landmanj@uci.edu
Contact: Victor Huyhn, BS 714.456.8176 vbhuynh@uci.edu

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Victor Huynh, BS    714-456-8176    vbhuynh@uci.edu   
Principal Investigator: Jaime Landman, MD         
Sub-Investigator: Gamal Ghoniem, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Jaime Landman, MD University of California, Irvine Department of Urology
  More Information

Publications:

Responsible Party: Jaime Landman, Department of Urology Chair, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02078895     History of Changes
Other Study ID Numbers: 2013-9702
Study First Received: February 26, 2014
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
Lower Urinary tract discomfort (frequency, urgency, nocturia, dysuria) and pain associated with ureteral stent placement

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014