CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 84 enrolled
Drug / intervention
Solifenacin succinate treatment +1 moredrug
Likely dose
Solifenacin succinate treatment 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01381120
NCT01381120Phase 4Completed

Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management

Barrie Urology Associates·interventional·Posted Jun 27, 2011·Updated Aug 30, 2012

In Brief

A Phase 4 clinical trial evaluating Solifenacin succinate treatment and Oxycodone and acetaminophen combination treatment for Flank Pain and Urinary Bladder, Overactive. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartOct 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.0 years ago

Interventions

Solifenacin succinate treatmentdrug

Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months

Oxycodone and acetaminophen combination treatmentdrug

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