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Completed

NCT Number: NCT01381120

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Barrie, Ontario, L4M 7G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Subject inclusion criteria.

  • 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.

Subject exclusion criteria.

  • 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.

Treatment and study plan

Solifenacin succinate treatment

Drug

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

Other names: VESIcare

Oxycodone and acetaminophen combination treatment

Drug

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

Primary outcomes

  1. Change in Post-ureteroscopy Stent-induced Pain

    Time frame: Baseline and 3 months.

    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.

Secondary outcomes

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

    Time frame: Baseline and three months.

    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.

Sponsors and collaborators

Lead sponsor

Barrie Urology Associates

Other

Collaborators

  • Astellas Pharma Canada, Inc.

Registry information

Official study title

Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Aug 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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