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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Barrie Urology Associates

Current Primary Outcome: Change in Post-ureteroscopy Stent-induced Pain [ Time Frame: Baseline and 3 months. ]

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.


Original Primary Outcome: Reduction in post-ureteroscopy stent-induced episodes of pain [ Time Frame: Three months. ]

Measured through the use of three questionnaires.


Current Secondary Outcome: Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms. [ Time Frame: Baseline and three months. ]

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.


Original Secondary Outcome: Reduction in post-ureteroscopy stent-induced episodes of lower urinary tract symptoms. [ Time Frame: Three months. ]

Measured through the use of three questionnaires.


Information By: Barrie Urology Associates

Dates:
Date Received: September 2, 2010
Date Started: October 2010
Date Completion:
Last Updated: August 21, 2012
Last Verified: August 2012