Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
Information source: Barrie Urology Associates
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Flank Pain; Urinary Bladder, Overactive
Intervention: Solifenacin succinate treatment (Drug); Oxycodone and acetaminophen combination treatment (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Barrie Urology Associates Official(s) and/or principal investigator(s):
Joseph A Zadra, MD CM FRCSC, Principal Investigator, Affiliation: Barrie Urology Associates - The Male/Female Health and Research Centre
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Post-ureteroscopy Stent-induced Pain
Secondary outcome: Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Barrie Urology Associates - The Male/Female Health and Research Centre, Barrie, Ontario L4M 7G1, Canada
Additional Information
Related publications: 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. Review. 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. 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. 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. 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.
Starting date: October 2010
Last updated: August 21, 2012
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