Trial Outcomes & Findings for Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (NCT NCT01381120)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

84 participants

Primary outcome timeframe

Baseline and 3 months.

Results posted on

2012-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	VESIcare + Narcotic Painkiller	Narcotic Painkiller
Overall Study STARTED	50	27
Overall Study COMPLETED	39	18
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VESIcare + Narcotic Painkiller n=50 Participants	Narcotic Painkiller n=27 Participants	Total n=77 Participants Total of all reporting groups
Age Continuous	50.81 years STANDARD_DEVIATION 12.36 • n=5 Participants	57.54 years STANDARD_DEVIATION 18.73 • n=7 Participants	53 years STANDARD_DEVIATION 15.52 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	13 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VESIcare + Narcotic Painkiller n=39 Participants 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)	Narcotic Painkiller n=18 Participants Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Change in Post-ureteroscopy Stent-induced Pain	4.61 units on a scale Interval 3.75 to 5.46	3.11 units on a scale Interval 1.63 to 4.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VESIcare + Narcotic Painkiller n=39 Participants 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)	Narcotic Painkiller n=18 Participants Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.	1.90 units on a scale Interval 1.6 to 2.21	1.13 units on a scale Interval 0.82 to 1.43

Adverse Events

VESIcare + Narcotic Painkiller

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narcotic Painkiller

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph Zadra

Barrie Urology Associates

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place