Trial Outcomes & Findings for Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation (NCT NCT03750656)
NCT ID: NCT03750656
Last Updated: 2024-12-03
Results Overview
To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).
TERMINATED
PHASE4
5 participants
Three Years
2024-12-03
Participant Flow
Participant milestones
| Measure |
Hyoscyamine
Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort
Hyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
|
Tamsulosin
0.4 mg tab orally daily
Tamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Baseline characteristics by cohort
| Measure |
Hyoscyamine
n=4 Participants
Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort
Hyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
|
Tamsulosin
n=1 Participants
0.4 mg tab orally daily
Tamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Three YearsPopulation: Data not collected to complete data analysis for the patients enrolled.
To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three YearsPopulation: Data not collected to complete data analysis for the patients enrolled.
To determine if there is a difference between the amount of additional medications needed to treat stent related discomfort between patients receiving hyoscyamine versus those that receive tamsulosin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three YearsPopulation: Data not collected to complete data analysis for the patients enrolled.
To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort
Outcome measures
Outcome data not reported
Adverse Events
Tamsulosin
Hyoscyamine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Duchene
University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place