Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381120
• Other study ID #: ARC-2010-03
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2010
• Last updated: August 21, 2012
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Barrie Urology Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flank Pain
• Lower Urinary Tract Symptoms
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin succinate treatment
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)

Locations

Country	Name	City	State
Canada	Barrie Urology Associates - The Male/Female Health and Research Centre	Barrie	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Barrie Urology Associates	Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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

Outcome

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