Clinical trial NCT01381120
Conditions: 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
Sponsor: Barrie Urology Associates
Start date: 2010-10-01; Completion date: 2012-06-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:

Arms: arm 1: 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 2: Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Interventions: intervention 1: Solifenacin succinate treatment intervention 2: Oxycodone and acetaminophen combination treatment
Intervention descriptions: intervention 1: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months intervention 2: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)

Protocol documents: