Lower Urinary Tract Symptoms
Conditions
Brief summary
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents.
Detailed description
Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary system. Many studies have looked at methods to reduce these uncomfortable symptoms ranging from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is often the cause of their removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help control stent-related discomfort compared to the tamsulosin arm.
Interventions
DRUGHyoscyamine
Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
DRUGTamsulosin
Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized open-blind clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be 18 years of age or older * Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma * Patient must agree to abstain from other clinical studies during the study period
Exclusion criteria
* Patients younger than 18 years of age * Patients with chronic or pre-existing indwelling stents * Patients currently receiving anticholinergic or alpha blocker therapy * Patients with chronic opioid or analgesic usage * Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia * Patients with an active untreated urinary tract infection * Patients who are currently pregnant or nursing * Patients with allergies or contraindication to either tamsulosin or hyoscyamine * Patients on active chemotherapy * Patients currently receiving other investigational therapy * Patients who are unable to sign consent/answer questionnaire due to compromised mental capacity or language barrier (the questionnaire is not validated in other languages) * Patients who have a stent placed emergently for an obstructing stone or septic stone without immediate stone removal, * Any stents placed that will stay in for longer than 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ureteral Stent Symptom Questionnaire Score | Three Years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Medication Needed | Three Years | 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 |
| Factors That Determine if Additional Medication Needed | Three Years | To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 1 |
| Total | 5 |
Baseline characteristics
| Characteristic | Hyoscyamine | Tamsulosin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 4 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Ureteral Stent Symptom Questionnaire Score
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).
Time frame: Three Years
Population: Data not collected to complete data analysis for the patients enrolled.
Secondary
Additional Medication Needed
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
Time frame: Three Years
Population: Data not collected to complete data analysis for the patients enrolled.
Secondary
Factors That Determine if Additional Medication Needed
To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort
Time frame: Three Years
Population: Data not collected to complete data analysis for the patients enrolled.