Flank Pain, Urinary Bladder, Overactive
Conditions
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
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.
Interventions
DRUGSolifenacin succinate treatment
Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months
DRUGOxycodone and acetaminophen combination treatment
Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Sponsors
Astellas Pharma Canada, Inc.
Barrie Urology Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-ureteroscopy Stent-induced Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms. | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VESIcare + Narcotic Painkiller | 50 |
| Narcotic Painkiller | 27 |
| Total | 77 |
Baseline characteristics
| Characteristic | VESIcare + Narcotic Painkiller | Narcotic Painkiller | Total |
|---|---|---|---|
| Age Continuous | 50.81 years STANDARD_DEVIATION 12.36 | 57.54 years STANDARD_DEVIATION 18.73 | 53 years STANDARD_DEVIATION 15.52 |
| Sex: Female, Male Female | 33 Participants | 13 Participants | 46 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 27 |
| serious Total, serious adverse events | 0 / 50 | 0 / 27 |
Outcome results
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.
Time frame: Baseline and 3 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VESIcare + Narcotic Painkiller | Change in Post-ureteroscopy Stent-induced Pain | 4.61 units on a scale |
| Narcotic Painkiller | Change in Post-ureteroscopy Stent-induced Pain | 3.11 units on a scale |
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.
Time frame: Baseline and three months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VESIcare + Narcotic Painkiller | Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms. | 1.90 units on a scale |
| Narcotic Painkiller | Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms. | 1.13 units on a scale |