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

Primary Purpose

Flank Pain, Urinary Bladder, Overactive

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Solifenacin succinate treatment
Oxycodone and acetaminophen combination treatment
Sponsored by
Barrie Urology Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flank Pain focused on measuring Flank Pain, Lower Urinary Tract Symptoms, LUTS, Urgency, Nocturia, Frequency, Ureteroscopy, Kidney Stones, Stent, Incontinence, VESIcare, Ureter, Urinary Bladder, Overactive, OAB, Overactive Bladder Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barrie Urology Associates - The Male/Female Health and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VESIcare + Narcotic Painkiller

Narcotic Painkiller

Arm Description

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)

Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)

Outcomes

Primary Outcome Measures

Change in Post-ureteroscopy Stent-induced Pain
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.
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.

Full Information

First Posted
September 2, 2010
Last Updated
August 21, 2012
Sponsor
Barrie Urology Associates
Collaborators
Astellas Pharma Canada, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01381120
Brief Title
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barrie Urology Associates
Collaborators
Astellas Pharma Canada, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flank Pain, Urinary Bladder, Overactive
Keywords
Flank Pain, Lower Urinary Tract Symptoms, LUTS, Urgency, Nocturia, Frequency, Ureteroscopy, Kidney Stones, Stent, Incontinence, VESIcare, Ureter, Urinary Bladder, Overactive, OAB, Overactive Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VESIcare + Narcotic Painkiller
Arm Type
Experimental
Arm Description
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)
Arm Title
Narcotic Painkiller
Arm Type
Active Comparator
Arm Description
Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate treatment
Other Intervention Name(s)
VESIcare
Intervention Description
Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months
Intervention Type
Drug
Intervention Name(s)
Oxycodone and acetaminophen combination treatment
Intervention Description
Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Primary Outcome Measure Information:
Title
Change in Post-ureteroscopy Stent-induced Pain
Description
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.
Time Frame
Baseline and 3 months.
Secondary Outcome Measure Information:
Title
Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.
Description
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.
Time Frame
Baseline and three months.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject inclusion criteria. Post-ureteroscopy for stone management. Stent inserted for more than 5 days. No significant flank pain or LUTS prior to kidney stones/stent insertion. Complete agreement with and signing of Informed Consent form. Subject exclusion criteria. Significant flank pain or LUTS prior to kidney stones/stent insertion. Currently taking antimuscarinics or α1 blockers. Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Zadra, MD CM FRCSC
Organizational Affiliation
Barrie Urology Associates - The Male/Female Health and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrie Urology Associates - The Male/Female Health and Research Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20425092
Citation
Mendez-Probst CE, Fernandez A, Denstedt JD. Current status of ureteral stent technologies: comfort and antimicrobial resistance. Curr Urol Rep. 2010 Mar;11(2):67-73. doi: 10.1007/s11934-010-0091-y.
Results Reference
background
PubMed Identifier
19277623
Citation
Wang CJ, Huang SW, Chang CH. Effects of specific alpha-1A/1D blocker on lower urinary tract symptoms due to double-J stent: a prospectively randomized study. Urol Res. 2009 Jun;37(3):147-52. doi: 10.1007/s00240-009-0182-8. Epub 2009 Mar 10.
Results Reference
background
PubMed Identifier
18338955
Citation
Damiano R, Autorino R, De Sio M, Giacobbe A, Palumbo IM, D'Armiento M. Effect of tamsulosin in preventing ureteral stent-related morbidity: a prospective study. J Endourol. 2008 Apr;22(4):651-6. doi: 10.1089/end.2007.0257.
Results Reference
background
PubMed Identifier
19814699
Citation
Park SC, Jung SW, Lee JW, Rim JS. The effects of tolterodine extended release and alfuzosin for the treatment of double-j stent-related symptoms. J Endourol. 2009 Nov;23(11):1913-7. doi: 10.1089/end.2009.0173.
Results Reference
background
PubMed Identifier
12576846
Citation
Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.
Results Reference
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Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms

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