Clinical trial NCT01381120: Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Barrie Urology Associates
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2011-06-27
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Post-ureteroscopy Stent-induced Pain
timeFrame: Baseline and 3 months.
Secondary outcomes:
measure: Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.
timeFrame: Baseline and three months.
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Barrie Urology Associates - The Male/Female Health and Research Centre
state: Ontario
Study officials:
affiliation: Barrie Urology Associates - The Male/Female Health and Research Centre
name: Joseph A Zadra, MD CM FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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. doi: 10.1097/01.ju.0000049198.53424.1d.