MedDataX Logo

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).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Three Years

Results posted on

2024-12-03

Participant Flow

Participant milestones

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

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=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
4 participants
n=5 Participants
1 participants
n=7 Participants
5 participants
n=5 Participants

PRIMARY outcome

Timeframe: Three Years

Population: 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 Years

Population: 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 Years

Population: 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

Hyoscyamine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Tamsulosin

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. David Duchene

University of Kansas Medical Center

Phone: (913) 588-8721

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place