Trial Outcomes & Findings for Evaluation of Ureteral Stents in the Management of Stone Disease (NCT NCT02211313)
NCT ID: NCT02211313
Last Updated: 2019-06-05
Results Overview
The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline, day 7 post stent removal
Results posted on
2019-06-05
Participant Flow
Participant milestones
| Measure |
Ureteral Stent - Soft, 6 French
Subjects randomized to soft stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
Ureteral Stent - Hydrophobic, 6 French
Subjects randomized to hydrophobic stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
23
|
|
Overall Study
COMPLETED
|
12
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Ureteral Stent - Soft, 6 French
Subjects randomized to soft stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
Ureteral Stent - Hydrophobic, 6 French
Subjects randomized to hydrophobic stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
|---|---|---|
|
Overall Study
Treatment Failure
|
5
|
2
|
|
Overall Study
No Follow up Questionnaires
|
1
|
1
|
Baseline Characteristics
5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
Baseline characteristics by cohort
| Measure |
Ureteral Stent - Soft, 6 French
n=18 Participants
Subjects randomized to soft stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
Ureteral Stent - Hydrophobic, 6 French
n=23 Participants
Subjects randomized to hydrophobic stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
0 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
0 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
15 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
21 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
|
Age, Categorical
>=65 years
|
6 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
5 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
11 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
13 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
19 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
7 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
13 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
|
Race/Ethnicity, Customized
Race · African American
|
0 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
3 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
3 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
12 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
17 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
29 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
20 Participants
n=20 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
32 Participants
n=32 Participants • 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires.
|
PRIMARY outcome
Timeframe: Baseline, day 7 post stent removalThe 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.
Outcome measures
| Measure |
Ureteral Stent - Soft, 6 French
n=12 Participants
Subjects randomized to soft stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
Ureteral Stent - Hydrophobic, 6 French
n=20 Participants
Subjects randomized to hydrophobic stent, size 6 French
Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
|
|---|---|---|
|
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
Post: Pain rating 0-10 (Numeric)
|
0.7 Scores on a scale 0-10 (Numeric)
Standard Deviation 1.1
|
1.1 Scores on a scale 0-10 (Numeric)
Standard Deviation 2.1
|
|
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
Pre Stent: Pain rating 0-10 (Numeric)
|
1.3 Scores on a scale 0-10 (Numeric)
Standard Deviation 1.7
|
1.5 Scores on a scale 0-10 (Numeric)
Standard Deviation 2.3
|
|
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
In-Situ: Pain rating 0-10 (Numeric)
|
4.0 Scores on a scale 0-10 (Numeric)
Standard Deviation 3.5
|
4.8 Scores on a scale 0-10 (Numeric)
Standard Deviation 3.4
|
Adverse Events
Ureteral Stent - Soft, 6 French
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ureteral Stent - Hydrophobic, 6 French
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
Alana Desai, M.D.
Washington University School of Medicine
Phone: (314) 362-7581
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place