Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
Condition: Flank Pain; Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Flank Pain
Intervention: Solifenacin succinate treatment; Oxycodone and acetaminophen combination treatment
Intervention description: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months; Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Intervention MeSH terms: Acetaminophen; Oxycodone; Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Healthy volunteers: No
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

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.