Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Dr. Joseph Zadra, Barrie Urology Associates
ClinicalTrials.gov Identifier:
NCT01381120
First received: September 2, 2010
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

Most ureteral stent insertions follow ureteroscopy procedures for stone management. Stents are essentially designed to prevent the blockage of the ureter. Such blockage is often a result of inflammation caused by ureteroscopy procedures. The stent provides a secure passageway for urine as it travels from the kidneys to the bladder, circumventing potential urinary retention. In our community, only one kind of stent is used, and it is manufactured by Bard. Standard protocol involves the removal of the stent 5 to 8 days following insertion. If stenting is required for greater than 8 days, special accommodations will be made for you in this study.

Unfortunately, pain and lower urinary tract symptoms are often associated with the insertion and removal of stents. It is our goal to determine whether VESIcare is capable of relieving such symptoms.

As a prospective member of this study, you will be asked to complete three surveys. The first survey will ask you about your experiences of urinary urgency and pain before your surgery. If you are an emergency patient, you will be asked to remember your condition before the surgery, completing this questionnaire at your first post-op visit. If you are not an emergency patient, this survey will be completed before your surgery. If your stent is removed within 5 to 8 days of surgery, you will be asked to complete the second survey at the time of removal. You will then complete the final survey at a scheduled post-operative check-up 4 to 5 weeks later. If your stent remains inserted for greater than 8 days after surgery, you will be asked to complete the second survey 3 to 4 days after your stent was inserted. You will then complete the final survey, 7 to 8 weeks post-op.

Throughout this study, both VESIcare and non-VESIcare patients will be important in determining whether VESIcare truly is capable of relieving stent pain. As such, you will be randomly assigned to one of the two groups, those receiving VESIcare, and those who are not.


Condition Intervention Phase
Flank Pain
Urinary Bladder, Overactive
Drug: Solifenacin succinate treatment
Drug: Oxycodone and acetaminophen combination treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management

Resource links provided by NLM:


Further study details as provided by Barrie Urology Associates:

Primary Outcome Measures:
  • Change in Post-ureteroscopy Stent-induced Pain [ Time Frame: Baseline and 3 months. ] [ Designated as safety issue: No ]
    Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.


Secondary Outcome Measures:
  • Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms. [ Time Frame: Baseline and three months. ] [ Designated as safety issue: No ]
    Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.


Enrollment: 84
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VESIcare + Narcotic Painkiller
VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Drug: Solifenacin succinate treatment
Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months
Other Name: VESIcare
Drug: Oxycodone and acetaminophen combination treatment
Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Active Comparator: Narcotic Painkiller
Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Drug: Oxycodone and acetaminophen combination treatment
Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Subject inclusion criteria.

  1. Post-ureteroscopy for stone management.
  2. Stent inserted for more than 5 days.
  3. No significant flank pain or LUTS prior to kidney stones/stent insertion.
  4. Complete agreement with and signing of Informed Consent form.

Subject exclusion criteria.

  1. Significant flank pain or LUTS prior to kidney stones/stent insertion.
  2. Currently taking antimuscarinics or α1 blockers.
  3. Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.
  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: NCT01381120

Locations
Canada, Ontario
Barrie Urology Associates - The Male/Female Health and Research Centre
Barrie, Ontario, Canada, L4M 7G1
Sponsors and Collaborators
Barrie Urology Associates
Astellas Pharma Canada, Inc.
Investigators
Principal Investigator: Joseph A Zadra, MD CM FRCSC Barrie Urology Associates - The Male/Female Health and Research Centre
  More Information

Publications:
Responsible Party: Dr. Joseph Zadra, Chief of Urology, RVH, Barrie Urology Associates
ClinicalTrials.gov Identifier: NCT01381120     History of Changes
Other Study ID Numbers: ARC-2010-03
Study First Received: September 2, 2010
Results First Received: February 9, 2012
Last Updated: August 21, 2012
Health Authority: Canada: Health Canada

Keywords provided by Barrie Urology Associates:
Flank Pain
Lower Urinary Tract Symptoms
LUTS
Urgency
Nocturia
Frequency
Ureteroscopy
Kidney Stones
Stent
Incontinence
VESIcare
Ureter
Urinary Bladder, Overactive
OAB
Overactive Bladder Syndrome

Additional relevant MeSH terms:
Flank Pain
Lower Urinary Tract Symptoms
Urinary Bladder, Overactive
Pain
Signs and Symptoms
Urological Manifestations
Urinary Bladder Diseases
Urologic Diseases
Acetaminophen
Oxycodone
Solifenacin
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 20, 2014