Urinary Bladder, Overactive Clinical Trial
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
Verified date | August 2012 |
Source | Barrie Urology Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 a1 blockers. 3. Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Barrie Urology Associates - The Male/Female Health and Research Centre | Barrie | Ontario |
Lead Sponsor | Collaborator |
---|---|
Barrie Urology Associates | Astellas Pharma Canada, Inc. |
Canada,
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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and 3 months. | No |
Secondary | 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. | Baseline and three months. | No |
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