Trial Outcomes & Findings for Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain (NCT NCT01189071)
NCT ID: NCT01189071
Last Updated: 2016-11-21
Results Overview
Decreased post operative ureteral stent pain, evidenced by decreased pain scores, less ER visits/hospital admits, or patient phone calls for stent pain/difficulty, as compared to the "standard of care" patient with no preop Darifenacin
TERMINATED
NA
3 participants
24 months
2016-11-21
Participant Flow
Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.
Participant milestones
| Measure |
Darifenacin
3 days of preoperative darifenacin anticholinergic medication
Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery.
|
no Pill
The control group will have the standard of care which is no preoperative anticholinegic medication.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain
Baseline characteristics by cohort
| Measure |
Darifenacin
3 days of preoperative darifenacin anticholinergic medication
Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery.
|
no Pill
The control group will have the standard of care which is no preoperative anticholinegic medication.
|
Total
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
0
n=35 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
0
n=35 Participants
|
|
Gender
Female
|
—
|
—
|
0
n=35 Participants
|
|
Gender
Male
|
—
|
—
|
0
n=35 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
0
n=35 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.
Decreased post operative ureteral stent pain, evidenced by decreased pain scores, less ER visits/hospital admits, or patient phone calls for stent pain/difficulty, as compared to the "standard of care" patient with no preop Darifenacin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: end of study with 30 patients recruitedPopulation: Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.
Decreased use of narcotic and anticholinergic medication use postoperatively, compared to the "standard of care" patient
Outcome measures
Outcome data not reported
Adverse Events
Darifenacin
no Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place