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

Barrie Urology Associates

Status and phase: Completed; Phase 4

Conditions: Urinary Bladder, Overactive; Flank Pain

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01381120

ARC-2010-03

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

VESIcare + Narcotic Painkiller

Experimental group

Description:

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)

Treatment:

Drug: Solifenacin succinate treatment

Drug: Oxycodone and acetaminophen combination treatment

Narcotic Painkiller

Active Comparator group

Description:

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

Treatment:

Drug: Oxycodone and acetaminophen combination treatment