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

NCT01381120 | Completed Phase 4 Results DMC

• 1 other identifier: ARC-2010-03
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.

  Baseline and three months.

Study Arms (2)

VESIcare + Narcotic Painkiller

EXPERIMENTAL

VESIcare: 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)

Drug: Solifenacin succinate treatment; Drug: Oxycodone and acetaminophen combination treatment

Narcotic Painkiller

ACTIVE COMPARATOR

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

Drug: Oxycodone and acetaminophen combination treatment

Interventions

Solifenacin succinate treatment DRUG

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

Also known as: VESIcare

VESIcare + Narcotic Painkiller

Oxycodone and acetaminophen combination treatment DRUG

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

Narcotic Painkiller; VESIcare + Narcotic Painkiller

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-ureteroscopy for stone management.
• Stent inserted for more than 5 days.
• No significant flank pain or LUTS prior to kidney stones/stent insertion.
• Complete agreement with and signing of Informed Consent form.

You may not qualify if:

• Significant flank pain or LUTS prior to kidney stones/stent insertion.
• Currently taking antimuscarinics or α1 blockers.
• Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.

Sponsors & Collaborators

• Barrie Urology Associates: lead
• Astellas Pharma Canada, Inc.: collaborator

Study Sites (1)

Barrie Urology Associates - The Male/Female Health and Research Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Related Publications (5)

• 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.

  PMID: 20425092 BACKGROUND

• 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.

  PMID: 19277623 BACKGROUND

• 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.

  PMID: 18338955 BACKGROUND

• 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.

  PMID: 19814699 BACKGROUND

• 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.

  PMID: 12576846 BACKGROUND

MeSH Terms

Conditions

Flank Pain; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Nocturia; Kidney Calculi

Interventions

Solifenacin Succinate; Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Nephrolithiasis; Kidney Diseases; Urolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Joseph Zadra
• Organization: Barrie Urology Associates

joezadra@rogers.com

Study Officials

• Joseph A Zadra, MD CM FRCSC

  Barrie Urology Associates - The Male/Female Health and Research Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Urology, RVH

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: June 27, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 30, 2012
• Results First Posted: August 22, 2012

Record last verified: 2012-08

Locations

CA (1)